Identity
- Trade Name
- Parietex FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
- Device Name
- Lightweight Mesh,Monofilament Polyester FDA UDI
- Model / Reference
- TCM2020X3 FDA UDI
- Description
- Lightweight Mesh,Monofilament Polyester FDA UDI
Identifiers
- Catalog Number
- TCM2020X3 FDA UDI
- Primary DI / UDI-DI
- 10884521178908 FDA UDI
- 510(k) Number
- K090858 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Width — 20 Centimeter FDA UDILength — 20 Centimeter FDA UDI
Parietex by Sofradim Production — Class II — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sofradim Production
Sources (1)
- FDA UDI 3ea2cdec-5e44-4bd9-b331-044a25229b33 38 fields · synced Jun 6, 2026