Home GUDID M8517000501 i-FACTOR™ Peptide Enhanced Bone Graft
Primary DI M8517000501
Brand i-FACTOR™ Peptide Enhanced Bone Graft
Company Cerapedics Inc.
Model 700-050
Catalog number 700-050
Device description i-FACTOR™ Putty, 5.0 cc Syringe
Published 2016-01-12
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 M8517000501 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone void filling material, animal-derived, bioabsorbable A bioabsorbable, implantable device made primarily of animal-derived (e.g., bovine) materials intended to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it is not dedicated to dental applications. 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 bone cavities, defects, and fractures. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 0
Regulatory Flags# DUNS number 800339702 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 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 M8517000251 i-FACTOR Peptide Enhanced Bone Graft 700-025 700-025 2017-06-26 00850001680196 PearlMatrix P-15 Peptide Enhanced Bone Graft, 1.0cc 730-010 2025-07-03 00850001680202 PearlMatrix P-15 Peptide Enhanced Bone Graft, 2.5cc 730-025 2025-07-03 00850001680219 PearlMatrix P-15 Peptide Enhanced Bone Graft, 5.0cc 730-050 2025-07-03 00850001680226 PearlMatrix P-15 Peptide Enhanced Bone Graft, 10.0cc 730-100 2025-07-03 00850001680004 i-FACTOR Peptide Enhanced Bone Graft 700-010 700-010 2020-04-06 00850001680011 i-FACTOR Peptide Enhanced Bone Graft 700-025 700-025 2020-04-06 00850001680028 i-FACTOR™ Peptide Enhanced Bone Graft 700-050 700-050 2020-04-06 M8517000101 i-FACTOR Peptide Enhanced Bone Graft 700-010 700-010 2017-06-26
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 10859477002140 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 10859477002041 AUGMENT Bone Graft Biomimetic Therapeutics, LLC NOX 2015-09-30
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