Home GUDID 10859477002140 AUGMENT® Injectable
Primary DI 10859477002140
Brand AUGMENT® Injectable
Company Biomimetic Therapeutics, LLC
Model K30003010
Catalog number K30003010
Device description Injectable Kit
Published 2018-06-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name NOX Filler, Bone Void, Synthetic Peptide
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NOX Filler, Bone Void, Synthetic Peptide Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10859477002140 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10859477002140 10859477002140
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone void filling material, synthetic, bioabsorbable, non-antimicrobial A bioabsorbable, implantable device made of a synthetic material(s) intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications and does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. Also referred to as a graft, matrix, or void filler, it typically provides an osteoconductive scaffold that promotes bone growth, and is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It may have adhesive properties.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Do not Freeze Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 078774659 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product true Lot or batch true Serial number false Manufacturing date on label true 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 10859477002034 AUGMENT® Bone Graft K20001510 K20001510 2016-04-05 10859477002041 AUGMENT Bone Graft K20003010 K20003010 2015-09-30 10859477002133 AUGMENT® Injectable K30001510 K30001510 2018-06-12
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850001680196 PearlMatrix P-15 Peptide Enhanced Bone Graft, 1.0cc Cerapedics Inc. NOX 2025-07-03 00850001680202 PearlMatrix P-15 Peptide Enhanced Bone Graft, 2.5cc Cerapedics Inc. NOX 2025-07-03 00850001680219 PearlMatrix P-15 Peptide Enhanced Bone Graft, 5.0cc Cerapedics Inc. NOX 2025-07-03 00850001680226 PearlMatrix P-15 Peptide Enhanced Bone Graft, 10.0cc Cerapedics Inc. NOX 2025-07-03 00850001680004 i-FACTOR Peptide Enhanced Bone Graft Cerapedics Inc. NOX 2020-04-06 00850001680011 i-FACTOR Peptide Enhanced Bone Graft Cerapedics Inc. NOX 2020-04-06 00850001680028 i-FACTOR™ Peptide Enhanced Bone Graft Cerapedics Inc. NOX 2020-04-06 10859477002133 AUGMENT® Injectable Biomimetic Therapeutics, LLC NOX 2018-06-12 M8517000251 i-FACTOR Peptide Enhanced Bone Graft Cerapedics Inc. NOX 2017-06-26 M8517000101 i-FACTOR Peptide Enhanced Bone Graft Cerapedics Inc. NOX 2017-06-26 10859477002034 AUGMENT® Bone Graft Biomimetic Therapeutics, LLC NOX 2016-04-05 M8517000501 i-FACTOR™ Peptide Enhanced Bone Graft Cerapedics Inc. NOX 2016-01-12 10859477002041 AUGMENT Bone Graft Biomimetic Therapeutics, LLC NOX 2015-09-30
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