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FDA-Registered Company Profile for COOK UROLOGICAL, INC.
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| FDA-Supplied Establishment Information: |
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| Establishment Registration Number: |
1825146 |
| Company Name: |
COOK UROLOGICAL, INC. |
| Also Known As: |
VPI
COOK OB/GYN
VANCE PRODUCTS, INC.
|
| Address: |
1100 WEST MORGAN ST. |
| Address 2: |
|
| City: |
SPENCER |
| State |
IN |
| Zip / Postal Code: |
47460 |
| County: |
OWEN |
| Country: |
US |
| Establishment Operation Code(s): |
ME - Contract Manufacturer
MM - Manufacturer
MR - Remanufacturer
MS - Specification Developer
RR - Repackager/Relabeller
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| Establishment Status Code: |
A -
Active
|
Year of Most Recent Initial or Annual Registration: |
2007 |
| FDA-Supplied Owner/Operator Information: |
| Owner/Operator Number: |
1825146 |
| Company Name: |
COOK UROLOGICAL, INC.
|
| Address: |
1100 WEST MORGAN ST. |
| Address 2: |
P.O. BOX 227 |
| City: |
SPENCER |
| State: |
IN |
| Zip / Postal Code: |
47460 |
| Country: |
US |
| Owner/Operator Phone: |
812-829-4891
|
| FDA-Supplied Official Correspondent Information: |
| Official Correspondent Name: |
MR. PETE YONKMAN |
| Company Name: |
COOK UROLOGICAL, INC. |
| Address: |
1100 WEST MORGAN ST. |
| Address 2: |
|
| City: |
SPENCER |
| State: |
IN |
| Zip / Postal Code: |
47460 |
| Country: |
US |
| Official Corespondent Phone Number: |
812-829-4891
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| Other Establishment Information: |
| Establishment Phone: |
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| Fax: |
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| General Email: |
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| Web Site: |
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| Company Brochure: |
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| Keywords: |
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| Company Description: |
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| Services Offered: |
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| About Us: |
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| Differentiation: |
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FDA-Registered Products Offered by COOK UROLOGICAL, INC.
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Common Device Name |
Proprietary Device Name |
| 1 |
Product Detail |
VIEW PRODUCT DETAIL |
| 2 |
Product Detail |
VIEW PRODUCT DETAIL |
| 3 |
Product Detail |
SURGICAL TISSUE POUCH |
| 4 |
Product Detail |
ILLUMINATED URETHERAL CATHETER |
| 5 |
Product Detail |
HYSTEROSCOPE & LAPAROSCOPE MYOMA SCREW |
| 6 |
Product Detail |
VANCE DILATOR SET |
| 7 |
Product Detail |
LAPAROSTAT |
| 8 |
ACTIVE CORDS |
VIEW PRODUCT DETAIL |
| 9 |
AMNIOCENTESIS NEEDLE |
ECHO-TIP NEEDLE |
| 10 |
BIOPSY NEEDLES, PROSTATIC ASPIRATOIN BIOPSY SET, QUICK CORE (R) BIOPSY NEEDLES |
UNI-COR BIOPSY NEEDLE, GASTROENTEROLOGY-UROLOGY DEVICES & BIOPSY INSTRUMENTS |
| 11 |
CANNULA, MANIPULATOR/INJECTOR, UTERINE |
INTRAUTERINE VENOGRAM NEEDLE SET |
| 12 |
CATHETER WIRE/GUIDE |
COOK(R) WIRE GUIDES |
| 13 |
CATHETER, URETERAL, PIGGY-BACK SET |
VIEW PRODUCT DETAIL |
| 14 |
CATHETERS, SALPINGOGRAPHY |
NOVY CORNUAL CANNULATION SET |
| 15 |
CERVICAL RIPENING BALLOON |
COOK CERVICAL BALLOON |
| 16 |
COOK ASPIRATION/IRRIGATION UNIT |
COOK ASPIRATION/IRRIGATION UNIT |
| 17 |
COOK CVS SET |
COOK CHORIONIC VILLUS SAMPLING SET |
| 18 |
COOK HYSTEROCATH; JANSEN-ANDERSON; SHEPARD; SHOLKOFF |
VIEW PRODUCT DETAIL |
| 19 |
DAVIS LOOP STONE EXTRACTOR |
VIEW PRODUCT DETAIL |
| 20 |
DISPOSIBLE INFLATION GUAGE |
VIEW PRODUCT DETAIL |
| 21 |
DRAINAGE CATHETERS AND ACCESSORIES |
COOK ADAPTER |
| 22 |
ENDOMETRIAL BRUSH |
ENDOMETRIAL SAMPLER |
| 23 |
FEMALE CONTINENCE DEVICE |
VIEW PRODUCT DETAIL |
| 24 |
FOLEY CATHETER TIP PUNCH |
FOLEY CATHETER TIP PUNCH |
| 25 |
INSTRUMENT BIOPSY BY SUCTION |
VANCE PROSTATIC ASPIRATION SET |
| 26 |
INTRODUCTION/DRAINAGE CATHETER AND ACCESSORIES |
COOK(R) DRAINAGE CONNECTOR |
| 27 |
INTRODUCTION/DRAINAGE CATHETERS AND ACCESSORIES |
COOK(R) BALLOON URETERAL DILATOR SET |
| 28 |
IRRIGATING SYRINGE |
COOK(R) SYRINGE ASSIST DEVICES |
| 29 |
LABCATH |
LABCATH |
| 30 |
LATERAL VAGINAL RETRACTOR |
LATERAL VAGINAL RETRACTOR |
| 31 |
MAGNETIC RETRIEVER |
MAGNETIC RETRIEVER |
| 32 |
MALLEABLE TIP FILIFORM |
VIEW PRODUCT DETAIL |
| 33 |
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
FOLEY CATHETER INTRODUCER |
| 34 |
MANUALLY POWERED,MANUALLY OPERATED BLADDER DRAINAGE DEVICE |
OFFICE VACUUM SET |
| 35 |
MANUFAL GSTROENTEROLOGY-UROLOGY SURGICAL INST. AND ACCOSSORIES |
REAPPROXIMATOR SET |
| 36 |
PENILE CLAMP |
COOK-VPI CONTINENCE CUFF |
| 37 |
REPRODUCTIVE MEDIA AND SUPPLEMENTS |
COOK(R) IVF MEDIA, COOK(R) SPERM PROCESSING SOLUTIONS |
| 38 |
SHEATH |
FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER |
| 39 |
SONOHYSTEROGRAPHY BIOPSY DEVICE |
COOK SONO-BIOPSY DEVICE |
| 40 |
SOUND |
SUPRAPUBLIC FOLEY INTRODUCER/SOUND |
| 41 |
SPERM FILTER DEVICE |
SPERM FILTER DEVICE |
| 42 |
STYLET FOR CATHETER, GASTRO-UROLOGY |
COOK UROLOGICAL WIRE GUIDE |
| 43 |
TISSUE BAG INTRODUCER, VARIOUS SIZES OF STERILE & NON-STERILE GENERAL USE INSTRU |
TISSUE BAG INTRODUCER, MULTIPLE |
| 44 |
URETERAL DILATOR SET |
COOK(R) URETERAL DILATOR SET |
| 45 |
URETERAL STENTS |
COOK(R) DOUBLE PIGTAIL URETERAL STENTS |
| 46 |
URETHRAL CATHETER |
FAIR URETHRAL STENT |
| 47 |
URETHRAL DILATOR |
PEEL-AWAY(R) SETS |
| 48 |
URINE COLLECTOR AND ACCESSORIES |
COOK(R) CONNECTING TUBES |
| 49 |
UROLOGICAL CATHETERS AND ACCESSORIES |
COOK(R) URETERAL CATHETERS |
| 50 |
VARIOUS SOUND, UTERINE PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 51 |
VARIOUS BLOOD PRESSURE CUFF PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 52 |
VARIOUS EXTRACTOR PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 53 |
VARIOUS ACCESSORIES, CATHETER, G-U PRODUCTS |
MULTIPLE PRODUCT NAMES |
| 54 |
VARIOUS OF SIZES OF STERILE AND NON-STERILE URETERAL DILATORS |
VIEW PRODUCT DETAIL |
| 55 |
VARIOUS SIZES AND STYLES OF NON-STERILE INSTRUMENT STERILIZATION CASES |
INSTRUMENT STERILIZATION CASE |
| 56 |
VARIOUS SIZES AND STYLES OF STERILE AND NON-STERILE WIRE GUIDE MANIPULATION HANS |
WIRE GUIDE MANIPULATION HANDLE |
| 57 |
VARIOUS SIZES AND STYLES OF STERLE AND NON-STERILE BALLOON HYSTEROSALPINGOGRAPHY |
BALLOON HYSTEROSALPINGOGRAPHY CATHETER |
| 58 |
VARIOUS SIZES AND TYPES OF ENDOSCOPE INSTRUMENTS & ACCESSORIES |
ENDOSCOPIC ACCESSORIES, COOK ADAPTER, CYSTOSCOPIC INJECTION NEEDLE |
| 59 |
VARIOUS SIZES AND TYPES OF STERILE & NON-STERILE BIOPSY NEEDLES AND SETS |
MULTIPLE PRODUCT NAMES |
| 60 |
VARIOUS SIZES AND TYPES OF STERILE & NON-STERILE LAPAROSCOPIC ACCESSORY DEVICES |
LAPAROSCOPIC ACCESSORY DEVICES |
| 61 |
VARIOUS SIZES AND TYPES OF STERILE & NON-STERILE PERITONEAL CATHETERS |
MULTIPLE PRODUCT NAMES |
| 62 |
VARIOUS SIZES AND TYPES OF STERILE AND NON-STERILE INTRAUTERINE INSEMINATION CAT |
INTRAUTERINE INSEMINATION CATHETERS AND SETS |
| 63 |
VARIOUS SIZES AND TYPES OF STERILE AND NON-STERILE SUMP DRAINAGE SETS |
MULTIPLE PRODUCT NAMES |
| 64 |
VARIOUS SIZES AND TYPES OF STERLE AND NON-STERILE UROLOGICAL CATHETERS |
MULTIPLE PRODUCT NAMES |
| 65 |
VARIOUS SIZES OF FACE MASKS |
GOTTENSMAN SPLASH-SHIELD; WHELAN STERI-SHIELD |
| 66 |
VARIOUS SIZES OF NON-STERILE PENILE MOLDS |
PENLE MOLD |
| 67 |
VARIOUS SIZES OF NON-STERILE URINARY BAGS |
VIEW PRODUCT DETAIL |
| 68 |
VARIOUS SIZES OF STERILE |
MULTIPLE PRODUCT NAMES |
| 69 |
VARIOUS SIZES OF STERILE & NN-STERILE CONNECTING TUBES |
VIEW PRODUCT DETAIL |
| 70 |
VARIOUS SIZES OF STERILE & NON-STERILE APPLICATORS |
MULTIPLE PRODUCT NAMES |
| 71 |
VARIOUS SIZES OF STERILE & NON-STERILE ENDOSCOPIC ELECTROSURGICAL DEVICES |
MULTIPLE PRODUCT NAMES |
| 72 |
VARIOUS SIZES OF STERILE & NON-STERILE FALLOPIAN TUBES |
MULTIPLE PRODUCT NAMES |
| 73 |
VARIOUS SIZES OF STERILE & NON-STERILE LIGATURE INSTRUMENTS |
MULTIPLE PRODUCT NAMES |
| 74 |
VARIOUS SIZES OF STERILE & NON-STERILE NEPHROSTOMY CATHETERS |
RETROGRADENEPHROSTOMY PUCTURE SET; ANESTHETIC INJECTION CATH |
| 75 |
VARIOUS SIZES OF STERILE & NON-STERILE RETRACTORS |
MULTIPLE PRODUCT NAMES |
| 76 |
VARIOUS SIZES OF STERILE & NON-STERILE SURGICAL CLAMPS |
MULTIPLE PRODUCT NAMES |
| 77 |
VARIOUS SIZES OF STERILE & NON-STERILE SURGICAL SNARES |
MULTIPLE PRODUCT NAMES |
| 78 |
VARIOUS SIZES OF STERILE & NON-STERILE SYRINGES |
MULTIPLE PRODUCT NAMES |
| 79 |
VARIOUS SIZES OF STERILE & NON-STERILE URETHERAL CATHETERS |
VIEW PRODUCT DETAIL |
| 80 |
VARIOUS SIZES OF STERILE AND NON-STERILE ADHESIVE TAPE |
HY-TAPE |
| 81 |
VARIOUS SIZES OF STERILE AND NON-STERILE BALLOON CATHETERS |
VIEW PRODUCT DETAIL |
| 82 |
VARIOUS SIZES OF STERILE AND NON-STERILE BASKETS |
VIEW PRODUCT DETAIL |
| 83 |
VARIOUS SIZES OF STERILE AND NON-STERILE BILIARY CATHS |
MULTIPLE PRODUCT NAMES |
| 84 |
VARIOUS SIZES OF STERILE AND NON-STERILE BIOPSY BRUSHES |
MULTIPLE PRODUCT NAMES |
| 85 |
VARIOUS SIZES OF STERILE AND NON-STERILE BIOPSY FORCEPS |
MULTIPLE PRODUCT NAMES |
| 86 |
VARIOUS SIZES OF STERILE AND NON-STERILE CATHETERS |
MULTIPLE PRODUCT NAMES |
| 87 |
VARIOUS SIZES OF STERILE AND NON-STERILE CATHETERS AND ACCESSORIES |
MULTIPLE PRODUCT NAMES |
| 88 |
VARIOUS SIZES OF STERILE AND NON-STERILE CERVICAL DILATORS |
MULTIPLE PRODUCT NAMES |
| 89 |
VARIOUS SIZES OF STERILE AND NON-STERILE CYTOLOGY BRUSHES |
MULTIPLE PRODUCT NAMES |
| 90 |
VARIOUS SIZES OF STERILE AND NON-STERILE DRAINAGE DEVICES |
NON-ADHESIVE CONDOM CATHETER & DRAINAGE POUCHES |
| 91 |
VARIOUS SIZES OF STERILE AND NON-STERILE ENDOCERVICAL ASPIRATORS |
MULTIPLE PRODUCT NAMES |
| 92 |
VARIOUS SIZES OF STERILE AND NON-STERILE FORCEPS |
SOF-FLEX LAPROSCOPIC BASKET; VPI-AMBROSE RESECTOSCOPE FORCEP |
| 93 |
VARIOUS SIZES OF STERILE AND NON-STERILE GYNECOLOGICAL PACKING FORCEPS |
GYNECOLOGICAL PACKING FORCEPS |
| 94 |
VARIOUS SIZES OF STERILE AND NON-STERILE ILLUMINATING CATHETER SETS |
ILLUMINATING CATHETER SET |
| 95 |
VARIOUS SIZES OF STERILE AND NON-STERILE IRRIGATION CATHETERS |
MULTIPLE PRODUCT NAMES |
| 96 |
VARIOUS SIZES OF STERILE AND NON-STERILE LAPAROSCOPE CATHETERS |
LAPAROSCOPE CATHETERS |
| 97 |
VARIOUS SIZES OF STERILE AND NON-STERILE LASER FIBER CLEANING CATHETERS |
LASER FIBER DELIVERY AND/OR CLEANING CATHETER |
| 98 |
VARIOUS SIZES OF STERILE AND NON-STERILE LIGATURE CARRIERS |
MULTIPLE PRODUCT NAMES |
| 99 |
VARIOUS SIZES OF STERILE AND NON-STERILE MANUAL RADIONUCLIDE APPLICATORS |
MANUAL RADIONUCLIDE APPLICATORS |
| 100 |
VARIOUS SIZES OF STERILE AND NON-STERILE NEEDLE GUIDES |
MULTIPLE PRODUCT NAMES |
| 101 |
VARIOUS SIZES OF STERILE AND NON-STERILE NEEDLE HOLDERS |
MULTIPLE PRODUCT NAMES |
| 102 |
VARIOUS SIZES OF STERILE AND NON-STERILE NEEDLES |
MULTIPLE PRODUCT NAMES |
| 103 |
VARIOUS SIZES OF STERILE AND NON-STERILE NEEDLES |
MULTIPLE PRODUCT NAMES |
| 104 |
VARIOUS SIZES OF STERILE AND NON-STERILE PERCUTANEOUS CATHETERS |
VIEW PRODUCT DETAIL |
| 105 |
VARIOUS SIZES OF STERILE AND NON-STERILE PERCUTANEOUS CATHETERS |
VIEW PRODUCT DETAIL |
| 106 |
VARIOUS SIZES OF STERILE AND NON-STERILE PERCUTANEOUS INTRODUCERS |
VIEW PRODUCT DETAIL |
| 107 |
VARIOUS SIZES OF STERILE AND NON-STERILE REUSABLE ASPIRATION AND INJECTION NEEDL |
REUSABLE ASPIRATION AND INJECTION NEEDLES |
| 108 |
VARIOUS SIZES OF STERILE AND NON-STERILE SPECULUMS |
MULTIPLE PRODUCT NAMES |
| 109 |
VARIOUS SIZES OF STERILE AND NON-STERILE STOPCOCKS |
VIEW PRODUCT DETAIL |
| 110 |
VARIOUS SIZES OF STERILE AND NON-STERILE SUPRAPUBIC ACCESS DEVICES |
VIEW PRODUCT DETAIL |
| 111 |
VARIOUS SIZES OF STERILE AND NON-STERILE SUPRAPUBIC BALLOON CATHETERS |
VIEW PRODUCT DETAIL |
| 112 |
VARIOUS SIZES OF STERILE AND NON-STERILE SUPRAPUBIC DEVICES |
VIEW PRODUCT DETAIL |
| 113 |
VARIOUS SIZES OF STERILE AND NON-STERILE URETHROGRAPHIC CATHETERS |
VIEW PRODUCT DETAIL |
| 114 |
VARIOUS SIZES OF STERILE AND NON-STERILE URETHROGRAPHIC CATHETERS |
VIEW PRODUCT DETAIL |
| 115 |
VARIOUS SIZES OF STERILE AND NON-STERILE URODYNAMIC CATHETERS |
MULTIPLE PRODUCT NAMES |
| 116 |
VARIOUS SIZES OF STERILE AND NON-STERIOLE IRRIGATION CATHETERS |
MULTIPLE PRODUCT NAMES |
| 117 |
VARIOUS SIZES OF STERILE ASPIRATION CATHETERS |
BAGGISH ASPIRATION CATHETER |
| 118 |
VARIOUS SIZES OF SURIGICAL MESH |
SURGISIS |
| 119 |
VARIOUS SIZES OFSTERILE & NON-STERILE RETENTION DISCS |
VIEW PRODUCT DETAIL |
| 120 |
VARIOUS SUPRAPUBIC CATHETERS (AND ACCESSORIES) |
MULTIPLE PRODUCT NAMES |
| 121 |
VARIOUS TYPES |
MULTIPLE PRODUCT NAMES |
| 122 |
VARIOUS TYPES |
VARIOUS APRONS & PROTECTIVE GARMENTS |
| 123 |
VARIOUS TYPES & SIZES OF NON-STERILE CONDOM CATHETERS |
CONDOM CATHETER |
| 124 |
VARIOUS TYPES & SIZES OF REPRODUCTION CATHETERS/SETS |
MULTIPLE PRODUCT NAMES |
| 125 |
VARIOUS TYPES & SIZES OF STERILE & NON-STERILE DRAIN CLIPS |
DRAIN CLIP |
| 126 |
VARIOUS TYPES & SIZES OF STERILE & NON-STERILE EVACUATING CATHETERS |
EVACUATING CATHETERS |
| 127 |
VARIOUS TYPES & SIZES OF STERILE & NON-STERILE MEATAL FUNNELS |
MEATAL FUNNEL |
| 128 |
VARIOUS TYPES & SIZES OF STERILE & NON-STERILE STONE STRAINERS |
STONE STRAINER |
| 129 |
VARIOUS TYPES & SIZES OF STERILE & NON-STERILE SURGICAL CLIPS |
SURGICAL CLIP |
| 130 |
VARIOUS TYPES & SIZES OF STERILE & NON-STERILE SURGICAL INSTRUMENT GUIDES |
SURGICAL INSTRUMENT GUIDES |
| 131 |
VARIOUS TYPES & SIZES OF STERILE & NON-STERILE SURGICAL KNIVES |
SURGICAL KNIFE |
| 132 |
VARIOUS TYPES & SIZES OF STERILE & NON-STERLE ENDOSCOPIC ELECTROSURGICAL FLEXIBL |
ENDOSNARE |
| 133 |
VARIOUS TYPES & SIZES OF STERILE AND NON-STERILE DISPOSABLE INFLATION GAUGES |
DISPOSABLE INFLATION GAUGE |
| 134 |
VARIOUS TYPES & SIZES OF STERILE SURGICAL SPLASH SHIELDS |
SURGICAL SPLASH SHIELDS |
| 135 |
VARIOUS TYPES AND SIZES OF NON-STERILE INSTRUMENT GUARDS |
LITHOTRIPTOR THERAPY COLLAR |
| 136 |
VARIOUS TYPES AND SIZES OF NON-STERILE RADIOGRAPHIC RULERS |
RADIOGRAPHIC RULER |
| 137 |
VARIOUS TYPES AND SIZES OF STERILE & NON STERILE ASPIRATION CATHETERS |
ASPIRATION CATHETER |
| 138 |
VARIOUS TYPES AND SIZES OF STERILE & NON-STERILE BRUSH BIOPSY SETS |
BRUSH BIOPSY SET |
| 139 |
VARIOUS TYPES AND SIZES OF STERILE & NON-STERILE CUTTING & COAGULATION DEVICES |
DEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
| 140 |
VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE CATHETER RETENTION SYSTEMS |
CATHETER RETENTION SYSTEMS |
| 141 |
VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE LAPAROSCOPE LENS CLEANERS |
LAPAROSCOPIC LENS CLEANER |
| 142 |
VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE NEPHROSTOMY CATHETERS AND SES |
NEPHROSTOMY CATHETERS AND SETS |
| 143 |
VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE SUPRAPUBIC NEEDLES |
SUPRAPUBIC NEEDLES |
| 144 |
VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE SURGICAL TISSUE POUCHES |
SURGICAL TISSUE POUCHES |
| 145 |
VARIOUS TYPES AND SIZES OF STERILE AND NON-STERILE URODYNAMICS,URETHRAL PROFILOM |
MULTIPLE PRODUCT NAMES |
| 146 |
VARIOUS TYPES AND SIZES OF STERILE AND NON-STERLE UROLOGY SUGICAL INSTRUMENTS |
MULTIPLE PRODUCT NAMES |
| 147 |
VARIOUS TYPES AND SIZES OF STERLE AND NON-STERILE INTRAUTERINE INSEINATION CATHE |
INTRAUTERINE INSEMNATION CATHETERS |
| 148 |
VARIOUS TYPES OF ASSISTED REPRODUCTION ACCESSORIES |
MULTIPLE PRODUCT NAMES |
| 149 |
VARIOUS TYPES OF STERILE & NON-STERILE NON-MEDICATED GAUZE |
MULTIPLE PRODUCT NAMES |
| 150 |
VARIOUS TYPES OF UTERINE ACCESS DEVICES |
UTERINE ACCESS DEVICE |
| 151 |
VARIOUS VANCE UROSTOMY APPLIANCE-VANCE ILEOSTOMY APPLIANCE |
VIEW PRODUCT DETAIL |
| 152 |
VARIUOS SIZES OFSTERILE AND NON-STERILE UROLOGY TOURNIQUETS |
MULTIPLE PRODUCT NAMES |
| 153 |
WILLSCHER VAS REAPPROXIMATER SET |
VIEW PRODUCT DETAIL |
| All FDA-Registered products for this company are displayed above. |