Identity
- Trade Name
- SERI Contour FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, silk, bioabsorbable FDA UDI
- Device Name
- SERI Contour Surgical Scaffold 10cm x 25cm FDA UDI
- Model / Reference
- 95512 FDA UDI
- Description
- SERI Contour Surgical Scaffold 10cm x 25cm FDA UDI
Identifiers
- Catalog Number
- 95512 FDA UDI
- Primary DI / UDI-DI
- B611955121 FDA UDI
- 510(k) Number
- K172545 FDA UDI
- FDA Product Code
- OXF FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, silk, 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Width — 5 Centimeter FDA UDILength — 15 Centimeter FDA UDI
SERI Contour by Sofregen Medical, Inc. — 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 |
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Manufacturer
- Manufacturer
- Sofregen Medical, Inc.
Sources (1)
- FDA UDI 4cbbc922-0130-4d4c-9def-9ca0023e1a15 38 fields · synced Jun 8, 2026