Identity
- Trade Name
- Parietene DS FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, composite-polymer FDA UDI
- Device Name
- Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking FDA UDI
- Model / Reference
- PPDS12 FDA UDI
- Description
- Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521795389 FDA UDI
- 510(k) Number
- K163212 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, composite-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
Dimensions & Sizes
- Size
- Outer Diameter — 12 Centimeter FDA UDI
Category: Extra-gynaecological surgical mesh, composite-polymer
Parietene DS by Sofradim Production — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Extra-gynaecological surgical mesh, composite-polymer.
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Cleared under the same submission
K163212 also covers:
- Parietene DS — SOFRADIM PRODUCTION
- Parietene DS — SOFRADIM PRODUCTION
- Parietene DS — SOFRADIM PRODUCTION
- Parietene DS — SOFRADIM PRODUCTION
- Parietene DS — SOFRADIM PRODUCTION
- Parietene DS — SOFRADIM PRODUCTION
- Parietene DS — SOFRADIM PRODUCTION
- Parietene DS — SOFRADIM PRODUCTION
- Parietene DS — SOFRADIM PRODUCTION
- Parietene DS — SOFRADIM PRODUCTION
- Parietene DS — SOFRADIM PRODUCTION
- Parietene DS — 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 6c6ecdcb-b6f2-405f-a8e1-27cfdab46329 36 fields · synced May 30, 2026