OsteoSelect (DBM) Putty 10.0cc in a Syringe

GUDID 00849777003681

ONE (1) PACKAGE - CONTAINING 10.0cc

BACTERIN INTERNATIONAL, INC.

Bone matrix implant, human-derived
Primary Device ID00849777003681
NIH Device Record Key19d0fe31-db13-439e-8ccf-065a7c50122b
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoSelect (DBM) Putty 10.0cc in a Syringe
Version Model Number359100
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
GS100849777003681 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

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 Date2016-10-17

Devices Manufactured by BACTERIN INTERNATIONAL, INC.

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