Home GUDID 00858686006041 Bio V BP Bioactive Glass with DBM Putty
Primary DI 00858686006041
Brand Bio V BP Bioactive Glass with DBM Putty
Company AMEND SURGICAL, INC.
Model BGP001-01
Catalog number BGP001-01
Device description Synthetic bone void filler containing DBM for orthopedic applications, provided in a syringe dispenser
Published 2018-01-12
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 00858686006041 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 00858686006041 00858686006041 858686006041 0858686006041
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.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 1 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 37 Degrees Celsius
Regulatory Flags# DUNS number 080131031 Device count 1 HCT/P 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 00858686006089 NanoFUSE Bioactive Strip 50x25x7mm ASI209-10 2019-07-16 00858686006096 NanoFUSE Bioactive Strip 100x25x7mm ASI209-20 2019-07-16 00858686006003 NanoFuse Bioactive Matrix - 2.0 cc NAN109-02 NAN109-02 2016-08-12 00858686006010 NanoFuse Bioactive Matrix - 5.0 cc NAN109-05 NAN109-05 2016-08-12 00858686006027 NanoFuse Bioactive Matrix - 10.0 cc NAN109-10 NAN109-10 2016-08-12 00858686006034 NanoFuse Bioactive Matrix - 1.0 cc NAN109-01 NAN109-01 2018-01-12 00858686006058 Bio V BP Bioactive Glass with DBM Putty - 2.0 cc BGP001-02 BGP001-02 2017-11-10 00858686006065 Bio V BP Bioactive Glass with DBM Putty - 5.0 cc BGP001-05 BGP001-05 2017-11-10 00858686006072 Bio V BP Bioactive Glass with DBM Putty BGP001-10 BGP001-10 2017-11-10
Other Devices Sharing Product Codes# 
amendsurgical.com