FDA UDI
In Commercial Distribution
🇺🇸 United States
Montage Flowable 8cc
DI: 00850391007221
·
Model: OS-MON-1501FL
·
ABYRX, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Montage Flowable 8cc
- Primary DI
- 00850391007221
- Version / Model
- OS-MON-1501FL
- Company Name
- ABYRX, INC.
- Labeler DUNS
- 078818942
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-12
- Public Version
- 2
- Public Version Date
- 2021-03-10
- Public Version Status
- Update
- Public Device Record Key
- f4f09127-623b-4c89-9516-bf26e350af6f
Device Description
Packaging Contains: 1 Montage Flowable Syringe 8cc DI # 00850391007191 1 Montage Flowable Dispenser DI# 00850391007207 3 Montage Flowable Mixing Tips DI # 00850391007214
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| MTJ | Wax, Bone | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44811 | Bone wax, synthetic | A sterile, implantable device in the form of a sterile wax-like, putty-like, or paste material designed to stop bone bleeding by the creation of a physical barrier along the edges of bone that has been damaged by trauma or cut during a surgical procedure. When placed on the bone under moderate pressure it plugs the vascular openings in the bone and prevents further bleeding. It is typically made from biocompatible/bioabsorbable synthetic substances (e.g., water-soluble copolymers); its stickiness may be increased by warming and by additional handling and manipulation. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850391007221 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193052 | 000 |