Home GUDID 00854395004507 Oxiplex
Primary DI 00854395004507
Brand Oxiplex
Company Fziomed, Inc.
Model FPC-09010
Device description Absorbable gel for spine surgery
Published 2025-09-11
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name QVL Absorbable Gel For Intraoperative Use In Spine Surgery
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QVL Absorbable Gel For Intraoperative Use In Spine Surgery Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10854395004504 Package GS1 1 In Commercial Distribution 00854395004507 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10854395004504 10854395004504 00854395004507 00854395004507 854395004507 0854395004507
GMDN Terms# Term, Definition table Term Definition Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated A bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue and another following a surgical procedure; neither antimicrobials nor pharmaceuticals are included. It may be supplied as a barrier membrane, hydratable gel, or fluid dressing and is made of appropriate material (e.g., collagen- or hyaluronic acid-based) to reduce adhesion between adjacent anatomical structures.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 3 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 966718371 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10854395004504 Oxiplex FPC-09010 2025-09-11
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10854395004504 Oxiplex Fziomed, Inc. QVL 2025-09-11
fziomed.com