| Primary Device ID | 00849777008334 |
| NIH Device Record Key | 0956f37c-ffb7-44f9-a6e3-3dc8fc4dccfd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Axograft Crunch 2.5cc |
| Version Model Number | X090-0020-MX2.5CCS |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00849777008334 [Primary] |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-01 |
| 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 |