OsteoSelect (DBM) Putty 1.0cc in a Syringe

GUDID 00849777007559

ONE (1) PACKAGE - CONTAINING 1.0cc

BACTERIN INTERNATIONAL, INC.

Bone matrix implant, human-derived
Primary Device ID00849777007559
NIH Device Record Keyba4b96f2-f4e0-4cbd-b408-0a86b829a186
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteoSelect (DBM) Putty 1.0cc in a Syringe
Version Model Number359010
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
GS100849777007559 [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.

00849777010535 - DBM Putty 2.5cc-Syringe2019-11-27 ONE (1) PACKAGE - CONTAINING 2.5cc
00849777010542 - DBM Putty 5.0cc-Syringe2019-11-27 ONE (1) PACKAGE - CONTAINING 5.0cc
00849777010566 - DBM Putty 10.0cc-Syringe2019-11-27 ONE (1) PACKAGE - CONTAINING 10.0cc
00849777010306 - DBM Putty 2.5cc2019-11-14 ONE (1) PACKAGE - CONTAINING 2.5cc
00849777010313 - DBM Putty 5.0cc2019-11-14 ONE (1) PACKAGE - CONTAINING 5.0cc
00849777010320 - DBM Putty 10.0cc2019-11-14 ONE (1) PACKAGE - CONTAINING 10.0cc
00849777009683 - DBM Putty 0.5cc2019-08-13 ONE (1) PACKAGE - CONTAINING 0.5cc
00849777009690 - DBM Putty 2.5cc2019-08-13 ONE (1) PACKAGE - CONTAINING 2.5cc

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.