| Primary Device ID | 00850391007122 |
| NIH Device Record Key | d994ebd8-b303-4bed-a02f-1aec631e1a62 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Montage 5cc |
| Version Model Number | OS-MON-1001 |
| Company DUNS | 078818942 |
| Company Name | ABYRX, 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 | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00850391007122 [Primary] |
| MTJ | Wax,Bone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-11-21 |
| 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 |
| 00850391007320 - Montage Flowable Settable Bone Paste | 2023-11-24 Contains 1 Montage Flowable Cartridge 00850391007290 1 Montage Flowable Dispenser 00850391007306 3 Montage Flowable Static Mix |
| 00850391007238 - Permatage 5cc | 2023-11-01 |
| 00850391007269 - Putty Applicator Gun | 2023-04-03 |