Identity
- Trade Name
- Permacol FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- Surgical Implant FDA UDI
- Model / Reference
- P100308 FDA UDI
- Description
- Surgical Implant FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884523000085 FDA UDI
- 510(k) Number
- K120605 FDA UDI
- FDA Product Code
- FTM FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial 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
Dimensions & Sizes
- Size
- Length — 8 Centimeter FDA UDIWidth — 3 Centimeter FDA UDIDepth — 1 Millimeter FDA UDI
Category: Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Permacol by Sofradim Production — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial.
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery · U
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- Strattice Reconstructive Tissue Matrix — LIFECELL CORP · Class II
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- Strattice Reconstructive Tissue Matrix — LIFECELL CORP · Class II
- Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Medium — Smith & Nephew, Inc. · Class II
- XENMATRIX — Davol Inc. · Class II
- Gentrix® — ACELL, INC. · Class II
Cleared under the same submission
K120605 also covers:
- Permacol — SOFRADIM PRODUCTION
- Permacol — SOFRADIM PRODUCTION
- Permacol — SOFRADIM PRODUCTION
- Permacol — SOFRADIM PRODUCTION
- Permacol — SOFRADIM PRODUCTION
- Permacol — SOFRADIM PRODUCTION
- Permacol — SOFRADIM PRODUCTION
- Permacol — SOFRADIM PRODUCTION
- Permacol — SOFRADIM PRODUCTION
- Permacol — SOFRADIM PRODUCTION
- Permacol — SOFRADIM PRODUCTION
- Permacol — SOFRADIM PRODUCTION
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 f21ba1ad-1f55-42bf-9f25-e6971c208fdf 37 fields · synced May 30, 2026