Identity
- Trade Name
- SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE FDA PMA
- Generic Name
- Barrier, absorbable, adhesion FDA PMA
Identifiers
- PMA Number
- P950034 FDA PMA
- FDA Product Code
- MCN FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Seprafilm Adhesion Barrier is a sterile, bioresorbable, translucent and hydrophilic membrane composed of two anionic polysaccharides. It is intended as an adjunct in abdominal and pelvic surgery to reduce the incidence, extent, and severity of postoperative adhesions.
The device is supplied sterile and is for single-use only. It has received FDA PMA approval (P950034) and is classified as a Class III absorbable adhesion barrier. No MRI safety information is provided in the data.
Frequently asked questions
What is Seprafilm Adhesion Barrier made of?
Seprafilm Adhesion Barrier is composed of two anionic polysaccharides, specifically sodium hyaluronate and carboxymethylcellulose, which form a bioresorbable membrane.
Is Seprafilm Adhesion Barrier reusable?
No, Seprafilm Adhesion Barrier is supplied sterile and is intended for single-use only; it must not be reused.
What surgical procedures is Seprafilm Adhesion Barrier used in?
Seprafilm Adhesion Barrier is used as an adjunct in abdominal and pelvic surgery to reduce the incidence, extent, and severity of postoperative adhesions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SEPRAFILM - Baxter specialty Site, Seprafilm Adhesion Barrier | Baxter Pro US, SEPRAFILM - Baxter specialty Site, SEPRAFILM - Baxter Advanced Surgery, SEPRAFILM Adhäsions-Prophylaxe, Full Sheet 13x15 cm, 10 Stk.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P950034 | Class III | Active |
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Manufacturer
- Manufacturer
- Baxter Healthcare Corporation
Sources (1)
- FDA PMA P950034 24 fields · synced Oct 6, 2026