| Primary Device ID | 00850391007313 |
| NIH Device Record Key | c5f467a8-a470-42ff-b538-8cb894cd9e31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Montage Flowable Settable Bone Paste |
| Version Model Number | MON-BVF-1501FL |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850391007313 [Primary] |
| MQV | Filler, Bone Void, Calcium Compound |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-24 |
| Device Publish Date | 2023-11-16 |
| 00850391007320 | Contains 1 Montage Flowable Cartridge 00850391007290 1 Montage Flowable Dispenser 0085039100730 |
| 00850391007313 | 3 Montage Flowable Static Mix Tips to be used in conjunction with: 1 Montage Flowable Cartridge |
| 00850391007306 | Single use dispenser for MON-BVF-1501FL used in conjunction with: Montage Flowable BVF Tips 0085 |
| 00850391007290 | 8cc Cartridge |