Montage Flowable Settable Bone Paste

FDA UDI

Class II (US FDA UDI)

by Abyrx, Inc.

Identity

Trade Name: Montage Flowable Settable Bone Paste FDA UDI
Generic Name: Synthetic bone graft FDA UDI
Device Name: 8cc Cartridge FDA UDI
Model / Reference: MON-BVF-1501FL FDA UDI
Description: 8cc Cartridge FDA UDI

Identifiers

Primary DI / UDI-DI: 00850391007290 FDA UDI
FDA Product Code: MQV FDA UDI
OIS FDA UDI
GMDN Term: Synthetic bone graft FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3045 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Bone matrix implant, synthetic, non-antimicrobial Synthetic bone graft

Montage Flowable Settable Bone Paste by Abyrx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Bicera® Resorbable Bone Substitute — WILTROM INC. · Class II
InQu — Isto Technologies, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Abyrx, Inc.

Sources (1)

FDA UDI caed41bd-f985-4350-9b0c-5c004d1a1594 33 fields · synced Jun 6, 2026