DBM Putty 5.0cc-Syringe

GUDID 00849777010542

ONE (1) PACKAGE - CONTAINING 5.0cc

BACTERIN INTERNATIONAL, INC.

Bone matrix implant, human-derived
Primary Device ID00849777010542
NIH Device Record Key1977642c-3a12-4642-a8a7-9fbc29cb66b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDBM Putty 5.0cc-Syringe
Version Model NumberIS59P005
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

Phone1-888-886-9354
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100849777010542 [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 Date2019-11-27
Device Publish Date2019-11-19

Devices Manufactured by BACTERIN INTERNATIONAL, INC.

00849777010566 - DBM Putty 10.0cc-Syringe2019-11-27 ONE (1) PACKAGE - CONTAINING 10.0cc
00849777010542 - DBM Putty 5.0cc-Syringe2019-11-27ONE (1) PACKAGE - CONTAINING 5.0cc
00849777010542 - DBM Putty 5.0cc-Syringe2019-11-27 ONE (1) PACKAGE - CONTAINING 5.0cc
00849777010535 - DBM Putty 2.5cc-Syringe2019-11-27 ONE (1) PACKAGE - CONTAINING 2.5cc
00849777010320 - DBM Putty 10.0cc2019-11-14 ONE (1) PACKAGE - CONTAINING 10.0cc
00849777010313 - DBM Putty 5.0cc2019-11-14 ONE (1) PACKAGE - CONTAINING 5.0cc
00849777010306 - DBM Putty 2.5cc2019-11-14 ONE (1) PACKAGE - CONTAINING 2.5cc
00849777009645 - DBM Putty 1.0cc2019-01-18 ONE (1) PACKAGE - CONTAINING 1.0cc (jar)
00849777009638 - DBM Putty 10.0cc Syringe2019-01-10 ONE (1) PACKAGE - CONTAINING 10.0cc

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