Montage Flowable Settable Bone Paste

GUDID 00850391007290

8cc Cartridge

ABYRX, INC.

Synthetic bone graft
Primary Device ID00850391007290
NIH Device Record Keycaed41bd-f985-4350-9b0c-5c004d1a1594
Commercial Distribution StatusIn Commercial Distribution
Brand NameMontage Flowable Settable Bone Paste
Version Model NumberMON-BVF-1501FL
Company DUNS078818942
Company NameABYRX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850391007290 [Primary]

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-24
Device Publish Date2023-11-16

On-Brand Devices [Montage Flowable Settable Bone Paste]

00850391007320Contains 1 Montage Flowable Cartridge 00850391007290 1 Montage Flowable Dispenser 0085039100730
008503910073133 Montage Flowable Static Mix Tips to be used in conjunction with: 1 Montage Flowable Cartridge
00850391007306Single use dispenser for MON-BVF-1501FL used in conjunction with: Montage Flowable BVF Tips 0085
008503910072908cc Cartridge

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