Identity
- Trade Name
- Oxiplex FDA UDI
- Generic Name
- Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated FDA UDI
- Device Name
- Absorbable gel for spine surgery FDA UDI
- Model / Reference
- FPC-09010 FDA UDI
- Description
- Absorbable gel for spine surgery FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854395004507 FDA UDI
- 510(k) Number
- DEN240038 FDA UDI
- FDA Product Code
- QVL FDA UDI
- GMDN Term
- Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3047 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
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 3 Milliliter FDA UDI
Category: Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Oxiplex by FzioMed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated.
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- 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
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
- FzioMed, Inc.
Sources (1)
- FDA UDI cdf15c75-2683-48c1-b75d-8e4400256b8b 37 fields · synced May 29, 2026