| Primary Device ID | 00840085272325 |
| NIH Device Record Key | b5cc9833-f520-40b1-adae-bd3cba5abb01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AFIBER |
| Version Model Number | JBAC00100 |
| Catalog Number | JBAC00100 |
| Company DUNS | 073029645 |
| Company Name | Astura Medical |
| 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 | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | 4695015530 |
| parker@asturamedical.com | |
| Phone | 4695015530 |
| parker@asturamedical.com | |
| Phone | 4695015530 |
| parker@asturamedical.com | |
| Phone | 4695015530 |
| parker@asturamedical.com | |
| Phone | 4695015530 |
| parker@asturamedical.com | |
| Phone | 4695015530 |
| parker@asturamedical.com | |
| Phone | 4695015530 |
| parker@asturamedical.com | |
| Phone | 4695015530 |
| parker@asturamedical.com | |
| Phone | 4695015530 |
| parker@asturamedical.com | |
| Phone | 4695015530 |
| parker@asturamedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840085272325 [Primary] |
| MQV | Filler, Bone Void, Calcium Compound |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2025-12-10 |
| Device Publish Date | 2024-01-09 |
| 00840085272363 | AMATRIX, STRIP DEMINERALIZED CANCELLOUS SPONGE, 50X20X5MM |
| 00840085272356 | AFIBER, FLOWABLE ALLOGRAFT FIBER BONE MATRIX, 10.0 CC |
| 00840085272349 | AFIBER, FLOWABLE ALLOGRAFT FIBER BONE MATRIX, 5.0 CC |
| 00840085272332 | AFIBER, BONE MORPHOGENETIC PROTEIN FIBER ALLOGRAFT, 15.0 CC |
| 00840085272325 | AFIBER, BONE MORPHOGENETIC PROTEIN FIBER ALLOGRAFT, 10.0 CC |
| 00840085272318 | AFIBER, BONE MORPHOGENETIC PROTEIN FIBER ALLOGRAFT, 5.0 CC |
| 00840085272301 | AFIBER, BONE MORPHOGENETIC PROTEIN FIBER ALLOGRAFT, 2.5 CC |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AFIBER 90776957 not registered Live/Pending |
Astura Medical Inc. 2021-06-16 |