Home GUDID 00858686006089 NanoFUSE Bioactive Strip
Primary DI 00858686006089
Brand NanoFUSE Bioactive Strip
Company AMEND SURGICAL, INC.
Model 50x25x7mm
Catalog number ASI209-10
Device description Bone void filler comprised of 45S5 bioactive glass and a gelatin carrier, intended for implantation
Published 2019-07-16
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 MQV Filler, Bone Void, Calcium Compound
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MQV Filler, Bone Void, Calcium Compound Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00858686006089 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 00858686006089 00858686006089 858686006089 0858686006089
GMDN Terms# Term, Definition table Term Definition Bone matrix implant, synthetic A sterile bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.
Device Sizes# Type, Value, Unit table Type Value Unit Length 50 Millimeter
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 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 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 00858686006041 Bio V BP Bioactive Glass with DBM Putty BGP001-01 BGP001-01 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