DBM Putty 2.5cc in a Syringe

GUDID 00849777008136

ONE (1) PACKAGE - CONTAINING 2.5cc

BACTERIN INTERNATIONAL, INC.

Bone matrix implant, human-derived
Primary Device ID00849777008136
NIH Device Record Keya5d6de14-969f-4a21-8aaa-0a1a4f66c8e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDBM Putty 2.5cc in a Syringe
Version Model NumberBXS-600-025-M
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
GS100849777008136 [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

On-Brand Devices [DBM Putty 2.5cc in a Syringe]

00849777008136ONE (1) PACKAGE - CONTAINING 2.5cc
00849777007733ONE (1) PACKAGE - CONTAINING 2.5cc
00849777006361ONE (1) PACKAGE - CONTAINING 2.5cc
00849777006354ONE (1) PACKAGE - CONTAINING 2.5cc
00849777005142ONE (1) PACKAGE - CONTAINING 2.5cc
00849777004824ONE (1) PACKAGE - CONTAINING 2.5cc

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