Primary Device ID | 00850391007290 |
NIH Device Record Key | caed41bd-f985-4350-9b0c-5c004d1a1594 |
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 | MR Safe |
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 | 00850391007290 [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 |