Home GUDID 00816125021949
B-GENIN Strip
Primary DI 00816125021949
Brand B-GENIN Strip
Company BERKELEY ADVANCED BIOMATERIALS, LLC
Model BG2-50X20-08
Catalog number BG2-50X20-08
Device description B-GENIN is a bone void filler consisting of purified bovine collagen and demineralized bone matrix (DBM). The collagen component is biocompatible. After it is implanted, it resorbs and is later replaced by natural bone.B-GENIN is indicated for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. The product should be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process. The bone graft can be mixed blood prior to use at the physician's discretion.
Published 2016-04-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) MQV Filler, Bone Void, Calcium Compound
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic 2 MQV Filler, Bone Void, Calcium Compound Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816125021949 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 00816125021949 00816125021949 816125021949 0816125021949
GMDN Terms# Term, Definition table Term Definition Cadaveric-donor/synthetic mineral bone graft A sterile implantable device consisting of demineralized bone matrix (DBM) processed from cadaveric human bone (allograft) and mixed with bioabsorbable synthetic minerals (e.g., calcium phosphate), intended to fill bony voids or gaps in the skeletal system (e.g., spine, pelvis, extremities) that have been surgically or traumatically created; it may also serve as a bone graft extender. It is designed to be resorbed/remodelled and replaced by host bone during the healing process. It is typically supplied as a kit which requires mixing to form a putty-like substance prior to implantation.
Regulatory Flags# DUNS number 081067703 Device count 1 Combination product true Lot or batch true Serial number true Expiration date on label true Donation ID number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00816125027125 VitaFuse™ Bioactive Glass Graft 03-00021 03-00021 2026-07-06 00816125027132 VitaFuse™ Bioactive Glass Graft 03-00022 03-00022 2026-07-06 00816125027149 VitaFuse™ Bioactive Glass Graft 03-00023 03-00023 2026-07-06 00816125026487 ThriveSynth™ Bioactive Glass Foam Putty TSBGP-01 TSBGP-01 2026-05-19 00816125026494 ThriveSynth™ Bioactive Glass Foam Putty TSBGP-05 TSBGP-05 2026-05-19 00816125026500 ThriveSynth™ Bioactive Glass Foam Putty TSBGP-10 TSBGP-10 2026-05-19 00816125026517 ThriveSynth™ Bioactive Glass Foam Strip TSBGS1-50X10-01 TSBGS1-50X10-01 2026-05-19 00816125026524 ThriveSynth™ Bioactive Glass Foam Strip TSBGS2-50X10-02 TSBGS2-50X10-02 2026-05-19 00816125026531 ThriveSynth™ Bioactive Glass Foam Strip TSBGS1-50X10-02 TSBGS1-50X10-02 2026-05-19 00816125026548 ThriveSynth™ Bioactive Glass Foam Strip TSBGS2-50X10-05 TSBGS2-50X10-05 2026-05-19 00816125026555 ThriveSynth™ Bioactive Glass Foam Strip TSBGS1-50X25-06 TSBGS1-50X25-06 2026-05-19 00816125026562 ThriveSynth™ Bioactive Glass Foam Strip TSBGS1-100X25-10 TSBGS1-100X25-10 2026-05-19 00816125026579 ThriveSynth™ Bioactive Glass Foam Strip TSBGS1-100X25-12 TSBGS1-100X25-12 2026-05-19 00816125026586 ThriveSynth™ Bioactive Glass Foam Strip TSBGS1-100X25-15 TSBGS1-100X25-15 2026-05-19 00816125026593 ThriveSynth™ Collagen Foam Putty TSCFP-01 TSCFP-01 2026-05-19 00816125026609 ThriveSynth™ Collagen Foam Putty TSCFP-02 TSCFP-02 2026-05-19 00816125026616 ThriveSynth™ Collagen Foam Putty TSCFP-05 TSCFP-05 2026-05-19 00816125026623 ThriveSynth™ Collagen Foam Putty TSCFP-10 TSCFP-10 2026-05-19 00816125026630 ThriveSynth™ Collagen Foam Strip TSCFS1-50X10-01 TSCFS1-50X10-01 2026-05-19 00816125026647 ThriveSynth™ Collagen Foam Strip TSCFS1-50X10-02 TSCFS1-50X10-02 2026-05-19
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00816125027125 VitaFuse™ Bioactive Glass Graft BERKELEY ADVANCED BIOMATERIALS, LLC MQV 2026-07-06 00816125027132 VitaFuse™ Bioactive Glass Graft BERKELEY ADVANCED BIOMATERIALS, LLC MQV 2026-07-06 00816125027149 VitaFuse™ Bioactive Glass Graft BERKELEY ADVANCED BIOMATERIALS, LLC MQV 2026-07-06 ECUR9920302 VerteFrame curasan AG MQV 2026-06-25 ECUR9920305 VerteFrame curasan AG MQV 2026-06-25 ECUR9920310 VerteFrame curasan AG MQV 2026-06-25 ECURCCLF25100 CERACELL Ortho Foam curasan AG MQV 2026-06-25 ECURCCLF25250 CERACELL Ortho Foam curasan AG MQV 2026-06-25 ECURCCLF2550 CERACELL Ortho Foam curasan AG MQV 2026-06-25 ECURCCLM25100 CERACELL Ortho Foam curasan AG MQV 2026-06-25 ECURCCLM2512 CERACELL Ortho Foam curasan AG MQV 2026-06-25 ECURCCLM2525 CERACELL Ortho Foam curasan AG MQV 2026-06-25 ECURCCLM2550 CERACELL Ortho Foam curasan AG MQV 2026-06-25 ECURTFF1050 TriForm Flexible Foam Strip curasan AG MQV 2026-06-25 ECURTFF1100 TriForm Flexible Foam Strip curasan AG MQV 2026-06-25 ECURTFM1050 TriForm Moldable Foam curasan AG MQV 2026-06-25 ECURTFM1100 TriForm Moldable Foam curasan AG MQV 2026-06-25 00849777014052 Union DBM, 1cc Xtant Medical Holdings, Inc. MQV 2026-06-24 00849777014052 Union DBM, 1cc Xtant Medical Holdings, Inc. MBP 2026-06-24 00849777014069 Union DBM, 2.5cc Xtant Medical Holdings, Inc. MQV 2026-06-24 00849777014069 Union DBM, 2.5cc Xtant Medical Holdings, Inc. MBP 2026-06-24 00849777014076 Union DBM, 5cc Xtant Medical Holdings, Inc. MQV 2026-06-24 00849777014076 Union DBM, 5cc Xtant Medical Holdings, Inc. MBP 2026-06-24 00849777014083 Union DBM, 10cc Xtant Medical Holdings, Inc. MQV 2026-06-24 00849777014083 Union DBM, 10cc Xtant Medical Holdings, Inc. MBP 2026-06-24 06429810349293 Adaptos®Fuse Biomendex Oy MQV 2026-06-24 06429810349316 Adaptos®Fuse Biomendex Oy MQV 2026-06-24 06429810349330 Adaptos®Fuse Biomendex Oy MQV 2026-06-24 06429810349354 Adaptos®Fuse Biomendex Oy MQV 2026-06-24 W4184058150T0474 DBX® Musculoskeletal Transplant Foundation, Inc. MQV 2026-06-05