| Primary Device ID | 00850391007443 |
| NIH Device Record Key | c8efad91-2e36-4c4e-b56b-f960b832aef6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Abyrx Spatula Stand Alone |
| Version Model Number | OS-SPA |
| Company DUNS | 078818942 |
| Company Name | ABYRX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850391007443 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-16 |
| Device Publish Date | 2025-04-08 |
| 00850391007443 - Abyrx Spatula Stand Alone | 2025-04-16 |
| 00850391007443 - Abyrx Spatula Stand Alone | 2025-04-16 |
| 00850391007016 - Montage XT 5cc | 2025-04-15 |
| 00850391007436 - Montage CT 7cc | 2025-04-15 |
| 00850391007245 - Montage Settable Bone Putty | 2023-11-24 |
| 00850391007252 - Montage Settable Bone Putty | 2023-11-24 |
| 00850391007290 - Montage Flowable Settable Bone Paste | 2023-11-24 8cc Cartridge |
| 00850391007306 - Montage Flowable Settable Bone Paste | 2023-11-24 Single use dispenser for MON-BVF-1501FL used in conjunction with: Montage Flowable BVF Tips 00850391007313, and Montage Flowable |
| 00850391007313 - Montage Flowable Settable Bone Paste | 2023-11-24 3 Montage Flowable Static Mix Tips to be used in conjunction with: 1 Montage Flowable Cartridge 00850391007290 and 1 Montage Fl |