Home GUDID 00613994986146 GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)
Primary DI 00613994986146
Brand GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM)
Company MEDTRONIC SOFAMOR DANEK, INC.
Model A44115
Device description DBM A44115 15CC GRAFTON CRUNCH
Published 2015-07-20
Public version status Update
Distribution status Not 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 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 00613994986146 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 00613994986146 00613994986146 613994986146 0613994986146
GMDN Terms# Term, Definition table Term Definition Human-derived demineralized bone matrix implant An implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 830350380 Device count 1 DM exempt false Premarket exempt false HCT/P true Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number true Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00199284455788 BonVie+ ELUTE , INC. MQV 2025-08-13 00085412630731 ALTAPORE Apatech Ltd MQV 2020-11-05 00085412678146 ALTAPORE Apatech Ltd MQV 2020-11-05 00085412654362 ALTAPORE Apatech Ltd MQV 2019-12-11 00085412654379 ALTAPORE Apatech Ltd MQV 2019-12-11 00085412654386 ALTAPORE Apatech Ltd MQV 2019-12-11 00085412654393 ALTAPORE Apatech Ltd MQV 2019-12-11 00613994247612 PROGENIX® PUTTY and PROGENIX® PLUS MEDTRONIC SOFAMOR DANEK, INC. MQV 2019-03-29 00613994247612 PROGENIX® PUTTY and PROGENIX® PLUS MEDTRONIC SOFAMOR DANEK, INC. MBP 2019-03-29 00613994512758 MASTERGRAFT® Mini Granules MEDTRONIC SOFAMOR DANEK, INC. MQV 2018-11-18 00613994512765 MASTERGRAFT® Mini Granules MEDTRONIC SOFAMOR DANEK, INC. MQV 2018-11-18 00613994512772 MASTERGRAFT® Mini Granules MEDTRONIC SOFAMOR DANEK, INC. MQV 2018-11-18 00613994512789 MASTERGRAFT® Mini Granules MEDTRONIC SOFAMOR DANEK, INC. MQV 2018-11-18 00613994512796 MASTERGRAFT® Mini Granules MEDTRONIC SOFAMOR DANEK, INC. MQV 2018-11-18 00613994512802 MASTERGRAFT® Mini Granules MEDTRONIC SOFAMOR DANEK, INC. MQV 2018-11-18 00613994512819 MASTERGRAFT® Mini Granules MEDTRONIC SOFAMOR DANEK, INC. MQV 2018-11-18 00613994512826 MASTERGRAFT® Mini Granules MEDTRONIC SOFAMOR DANEK, INC. MQV 2018-11-18 00613994986467 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2015-12-01 00613994986474 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2015-12-01 00613994986481 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2015-12-01 00613994986498 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2015-12-01 00613994986504 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2015-12-01 00613994986511 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2015-12-01 00613994986528 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2015-12-01 00613994986535 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2015-12-01 00613994986542 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2015-12-01 00613994986559 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2015-12-01 00643169103986 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2015-12-01 00643169103993 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2015-12-01 00643169104006 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2015-12-01
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