Montage Flowable 8cc

FDA UDI

Class U (US FDA UDI)

by Abyrx, Inc.

Identity

Trade Name: Montage Flowable 8cc FDA UDI
Generic Name: Bone wax, synthetic FDA UDI
Device Name: Packaging Contains: 1 Montage Flowable Syringe 8cc DI # 00850391007191 1 Montage Flowable Dispenser DI# 00850391007207 3 Montage Flowable Mixing Tips DI # 00850391007214 FDA UDI
Model / Reference: OS-MON-1501FL FDA UDI
Description: Packaging Contains: 1 Montage Flowable Syringe 8cc DI # 00850391007191 1 Montage Flowable Dispenser DI# 00850391007207 3 Montage Flowable Mixing Tips DI # 00850391007214 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850391007221 FDA UDI
510(k) Number: K193052 FDA UDI
FDA Product Code: MTJ FDA UDI
GMDN Term: Bone wax, synthetic FDA UDI

Classification

Device Class: U 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

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

FDA UDI

Category: Bone wax, synthetic

Montage Flowable 8cc by Abyrx, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Ostene — Apatech Ltd · U
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Ostene — Apatech Ltd · U
Ostene — Apatech Ltd · U
Abyrx Spatula — ABYRX, INC. · U
AHBP 2.5 gram — ABYRX, INC. · U

Cleared under the same submission

K193052 also covers:

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 U	Pending data

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Manufacturer

Manufacturer: Abyrx, Inc.

Sources (1)

FDA UDI f4f09127-623b-4c89-9516-bf26e350af6f 34 fields · synced May 30, 2026