Identity
- Trade Name
- GYNECARE TVT FDA UDI
- Generic Name
- Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
- Device Name
- Abdominal Guides FDA UDI
- Model / Reference
- 810041A FDA UDI
- Description
- Abdominal Guides FDA UDI
Identifiers
- Catalog Number
- 810041A FDA UDI
- Primary DI / UDI-DI
- 10705031062283 FDA UDI
- FDA Product Code
- OTN FDA UDI
- GMDN Term
- Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Female stress urinary incontinence surgical mesh-sling, synthetic polymer
Gynecare Tvt by Ethicon Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Female stress urinary incontinence surgical mesh-sling, synthetic polymer.
- Desara Blue — CALDERA MEDICAL, INC. · Class II
- KIM (Knotless Incontinence Mesh) — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL · Class II
- Desara Blue TVez 3.0 — CALDERA MEDICAL, INC. · Class II
- Lynx™ System — Boston Scientific · Class II
- Desara TV — CALDERA MEDICAL, INC. · Class II
- Solyx™ SIS System — Boston Scientific · Class II
- Exair — Coloplast A/S · Class III
- Desara TV — CALDERA MEDICAL, INC. · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ethicon Sàrl
Sources (1)
- FDA UDI 7f835a2f-9e69-4823-8aa7-7498bd15ddaf 35 fields · synced May 30, 2026