DEVICE: Montage Flowable Settable Bone Paste (00850391007320)
Device Identifier (DI) Information
Montage Flowable Settable Bone Paste
MON-BVF-1501FL
In Commercial Distribution
ABYRX, INC.
MON-BVF-1501FL
In Commercial Distribution
ABYRX, INC.
Contains
1 Montage Flowable Cartridge 00850391007290
1 Montage Flowable Dispenser 00850391007306
3 Montage Flowable Static Mix Tips 00850391007313
Device Characteristics
MR Safe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
16966 | Synthetic bone graft |
An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.
|
Active | true |
17751 | Bone matrix implant, synthetic, non-antimicrobial |
A bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQV | Filler, Bone Void, Calcium Compound |
OIS | Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
d1ee55af-d807-4454-aa24-b8d4f9abb004
November 24, 2023
1
November 16, 2023
November 24, 2023
1
November 16, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined