Identity
- Trade Name
- Gelfilm FDA UDI
- Generic Name
- Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated FDA UDI
- Device Name
- Anti-adhesion dressing, bioabsorbable FDA UDI
- Model / Reference
- Gelfilm® Sterile Film Sterile film 1's (125 sq cm) FDA UDI
- Description
- Anti-adhesion dressing, bioabsorbable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00300090283018 FDA UDI
- FDA Product Code
- OOD FDA UDI
- GMDN Term
- Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated 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
Yes
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
- Width — 100 Millimeter FDA UDILength — 125 Millimeter FDA UDI
Gelfilm by Pharmacia & Upjohn Co. — 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
- Pharmacia & Upjohn Co.
Sources (1)
- FDA UDI 565636c1-b397-45f1-8990-183ba206909b 37 fields · synced Jun 1, 2026