Home GUDID M3860240005501 Accell TBM
Primary DI M3860240005501
Brand Accell TBM
Company ISOTIS ORTHOBIOLOGICS, INC.
Model 02-4000-550
Catalog number 02-4000-550
Device description Accell TBM, 5x5 - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM
Published 2015-09-24
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 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 10889981055653 Primary GS1 0 M3860240005501 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10889981055653 10889981055653
GMDN Terms# Term, Definition table Term Definition Bone matrix implant, human-derived An sterile 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
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 801089152 Device count 1 DM exempt false Premarket exempt false HCT/P true Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true 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 00643169964938 GRAFTON™ DBM MEDTRONIC SOFAMOR DANEK, INC. MQV 2024-12-05 00763000140502 PROGENIX™ PUTTY and PROGENIX™ PLUS MEDTRONIC SOFAMOR DANEK, INC. MQV 2021-03-12 00763000140519 PROGENIX™ PUTTY and PROGENIX™ PLUS MEDTRONIC SOFAMOR DANEK, INC. MQV 2021-03-12 00763000140526 PROGENIX™ PUTTY and PROGENIX™ PLUS MEDTRONIC SOFAMOR DANEK, INC. MQV 2021-03-12 00763000140533 PROGENIX™ PUTTY and PROGENIX™ PLUS MEDTRONIC SOFAMOR DANEK, INC. MQV 2021-03-12 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 00643169965089 GRAFTON® DBM MEDTRONIC SOFAMOR DANEK, INC. MQV 2019-02-07 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 00643169965065 GRAFTON® DBM MEDTRONIC SOFAMOR DANEK, INC. MQV 2018-01-26 00643169141858 MAGNIFUSE® Bone Graft MEDTRONIC SOFAMOR DANEK, INC. MQV 2017-07-23 00643169719361 MASTERGRAFT® Strip MEDTRONIC SOFAMOR DANEK, INC. MQV 2016-09-09 00643169719378 MASTERGRAFT® Strip MEDTRONIC SOFAMOR DANEK, INC. MQV 2016-09-09 00643169719385 MASTERGRAFT® Strip MEDTRONIC SOFAMOR DANEK, INC. MQV 2016-09-09 00643169218093 PLEXUR P® MEDTRONIC SOFAMOR DANEK, INC. MQV 2016-04-02 00643169218116 PLEXUR P® MEDTRONIC SOFAMOR DANEK, INC. MQV 2016-04-02 00643169218130 PLEXUR P® MEDTRONIC SOFAMOR DANEK, INC. MQV 2016-04-02