Identity
- Trade Name
- SEPRAFILM FDA UDI
- Generic Name
- Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated FDA UDI
- Device Name
- Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC). FDA UDI
- Model / Reference
- 430102 FDA UDI
- Description
- Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC). FDA UDI
Identifiers
- Catalog Number
- 430102 FDA UDI
- Primary DI / UDI-DI
- 05413765589614 FDA UDI
- PMA Number
- P950034 FDA UDI
- FDA Product Code
- MCN FDA UDI
- GMDN Term
- Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated FDA UDI
Classification
- Device Class
- Class III 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 — 5 Inch FDA UDIWidth — 6 Inch FDA UDI
Category: Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Seprafilm by Baxter Healthcare Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated.
- GYNECARE INTERCEED — Ethicon Inc. · Class III
- Seprafilm® — Genzyme Corp. · Class III
- Seprafilm® Procedure Pack — Genzyme Corp. · Class III
- Gelfilm — Pharmacia & Upjohn Co. · Class II
- Seprafilm® 4-section — Genzyme Corp. · Class III
- Adept Adhesion Reduction Solution — BAXTER INTERNATIONAL INC. · Class III
- Gelfilm — Pharmacia & Upjohn Co. · Class II
- Seprafilm® Single Site — Genzyme Corp. · Class III
Cleared under the same submission
P950034 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 III | Pending data |
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Manufacturer
- Manufacturer
- Baxter Healthcare Corp
Sources (1)
- FDA UDI 09fa7d58-56ec-4962-a2a6-0dd1181c0b95 38 fields · synced Jun 6, 2026