Identity
- Trade Name
- SUPRAFOIL FDA UDI
- Generic Name
- Orbital rim prosthesis FDA UDI
- Device Name
- SupraFOIL Nylon Foil Implant, 9x10cm, 0.35mm thickness FDA UDI
- Model / Reference
- Code F-LSS-05 FDA UDI
- Description
- SupraFOIL Nylon Foil Implant, 9x10cm, 0.35mm thickness FDA UDI
Identifiers
- Catalog Number
- Code F-LSS-05 FDA UDI
- Primary DI / UDI-DI
- 00816848024074 FDA UDI
- 510(k) Number
- K973379 FDA UDI
- FDA Product Code
- FTM FDA UDI
- GMDN Term
- Orbital rim prosthesis 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
Category: Orbital rim prosthesis
Suprafoil by S. Jackson, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MEDPOR — Stryker Leibinger · Class II
- SUPRAFOIL — S. Jackson, Inc. · Class II
- SUPRAFOIL — S. Jackson, Inc. · Class II
- SUPRAFOIL — S. Jackson, Inc. · Class II
- SUPRAFOIL — S. Jackson, Inc. · Class II
Cleared under the same submission
K973379 also covers:
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
- S. Jackson, Inc.
Sources (1)
- FDA UDI a8ca3438-2bea-4d52-937a-f31004c10688 36 fields · synced Jun 6, 2026