Home GUDID 10854395004504 Oxiplex
Primary DI 10854395004504
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
OTC false
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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00854395004507 Oxiplex FPC-09010 2025-09-11
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00854395004507 Oxiplex Fziomed, Inc. QVL 2025-09-11
fziomed.com