FDA UDI
In Commercial Distribution
🇺🇸 United States
Montage Flowable Settable Bone Paste
DI: 00850391007306
·
Model: MON-BVF-1501FL
·
ABYRX, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Montage Flowable Settable Bone Paste
- Primary DI
- 00850391007306
- Version / Model
- MON-BVF-1501FL
- Company Name
- ABYRX, INC.
- Labeler DUNS
- 078818942
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-16
- Public Version
- 1
- Public Version Date
- 2023-11-24
- Public Version Status
- New
- Public Device Record Key
- 77397886-de41-4270-8a86-ec43a9f6f296
Device Description
Single use dispenser for MON-BVF-1501FL used in conjunction with: Montage Flowable BVF Tips 00850391007313, and Montage Flowable BVF Paste 00850391007290
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | Orthopedic | 888.3045 | 2 |
| OIS | Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation | Orthopedic | 888.3045 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35809 | Orthopaedic cement dispenser | A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850391007306 | GS1 |