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Montage Flowable Settable Bone Paste
FDA UDIClass II (US FDA UDI)
by Abyrx, Inc.
Identity
- Trade Name
- Montage Flowable Settable Bone Paste FDA UDI
- Generic Name
- Orthopaedic cement dispenser FDA UDI
- Device Name
- 3 Montage Flowable Static Mix Tips to be used in conjunction with: 1 Montage Flowable Cartridge 00850391007290 and 1 Montage Flowable Dispenser 00850391007306 FDA UDI
- Model / Reference
- MON-BVF-1501FL FDA UDI
- Description
- 3 Montage Flowable Static Mix Tips to be used in conjunction with: 1 Montage Flowable Cartridge 00850391007290 and 1 Montage Flowable Dispenser 00850391007306 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850391007313 FDA UDI
- FDA Product Code
- MQV FDA UDIOIS FDA UDI
- GMDN Term
- Orthopaedic cement dispenser 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic cement dispenser
Montage Flowable Settable Bone Paste by Abyrx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic cement dispenser.
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- CarboClear Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD · Class II
- MiniMix™ Delivery Syringe — Summit Medical, LLC · Class I
- Vertebra Filler Device (Frontal Opening) — Joline GmbH & Co. KG · Class II
- KYPHON® Directional Bone Filler Device — MEDTRONIC SOFAMOR DANEK, INC. · Class I
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 c5f467a8-a470-42ff-b538-8cb894cd9e31 33 fields · synced May 31, 2026