Identity
- Trade Name
- GYNECARE TVT FDA UDI
- Generic Name
- Urethral manipulator FDA UDI
- Device Name
- Reusable Rigid Catheter Guide FDA UDI
- Model / Reference
- 810061 FDA UDI
- Description
- Reusable Rigid Catheter Guide FDA UDI
Identifiers
- Catalog Number
- 810061 FDA UDI
- Primary DI / UDI-DI
- 10705031062245 FDA UDI
- FDA Product Code
- KOA FDA UDI
- GMDN Term
- Urethral manipulator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Urethral manipulator
Gynecare Tvt by Ethicon Sàrl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Sàrl
Sources (1)
- FDA UDI 2835edad-a53d-41df-80f3-f8ac8a8a3247 35 fields · synced May 30, 2026