DBM Putty 1.0cc

GUDID 00849777009645

ONE (1) PACKAGE - CONTAINING 1.0cc (jar)

BACTERIN INTERNATIONAL, INC.

Bone matrix implant, human-derived
Primary Device ID00849777009645
NIH Device Record Keyd361c83e-4713-4405-bb4b-afcf05301b77
Commercial Distribution StatusIn Commercial Distribution
Brand NameDBM Putty 1.0cc
Version Model NumberBM895010
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

Customer Support Contacts

Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com
Phone+1(888)886-9354
Emailcs@xtantmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100849777009645 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-18
Device Publish Date2018-12-18

On-Brand Devices [DBM Putty 1.0cc]

00849777009645ONE (1) PACKAGE - CONTAINING 1.0cc (jar)
00849777008693ONE (1) PACKAGE - CONTAINING 1.0cc
00849777008648ONE (1) PACKAGE - CONTAINING 1.0cc (jar)
00849777004534ONE (1) PACKAGE - CONTAINING 1.0cc
00849777003704ONE (1) PACKAGE - CONTAINING 1.0cc

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