GTR DBM Putty 2.5cc

GUDID 00849777004329

ONE (1) PACKAGE - CONTAINING 2.5cc

BACTERIN INTERNATIONAL, INC.

Bone matrix implant, human-derived

• Primary Device ID: 00849777004329
• NIH Device Record Key: 36fc0c26-8b65-421e-a9b7-385d72063a4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GTR DBM Putty 2.5cc
• Version Model Number: GTR-02P
• Company DUNS: 829387302
• Company Name: BACTERIN INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849777004329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130498

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-17

Devices Manufactured by BACTERIN INTERNATIONAL, INC.

• 00849777010535 - DBM Putty 2.5cc-Syringe: 2019-11-27 ONE (1) PACKAGE - CONTAINING 2.5cc
• 00849777010542 - DBM Putty 5.0cc-Syringe: 2019-11-27 ONE (1) PACKAGE - CONTAINING 5.0cc
• 00849777010566 - DBM Putty 10.0cc-Syringe: 2019-11-27 ONE (1) PACKAGE - CONTAINING 10.0cc
• 00849777010306 - DBM Putty 2.5cc: 2019-11-14 ONE (1) PACKAGE - CONTAINING 2.5cc
• 00849777010313 - DBM Putty 5.0cc: 2019-11-14 ONE (1) PACKAGE - CONTAINING 5.0cc
• 00849777010320 - DBM Putty 10.0cc: 2019-11-14 ONE (1) PACKAGE - CONTAINING 10.0cc
• 00849777009683 - DBM Putty 0.5cc: 2019-08-13 ONE (1) PACKAGE - CONTAINING 0.5cc
• 00849777009690 - DBM Putty 2.5cc: 2019-08-13 ONE (1) PACKAGE - CONTAINING 2.5cc