Axograft Crunch 5cc - Jar

GUDID 00849777008310

ONE (1) PACKAGE - CONTAINING 5.0cc

BACTERIN INTERNATIONAL, INC.

Bone matrix implant, human-derived
Primary Device ID00849777008310
NIH Device Record Key20d44704-b91a-4a78-a26d-094afd4e765a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxograft Crunch 5cc - Jar
Version Model NumberX090-0020-MX5CCJ
Company DUNS829387302
Company NameBACTERIN INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100849777008310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-01

Devices Manufactured by BACTERIN INTERNATIONAL, INC.

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