FDA UDI
In Commercial Distribution
🇺🇸 United States
Constrictor - Syndesmosis Knotless Adjustable Button System
DI: 00854629006697
·
Model: AB-2200
·
DUNAMIS MEDICAL, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Constrictor - Syndesmosis Knotless Adjustable Button System
- Primary DI
- 00854629006697
- Version / Model
- AB-2200
- Catalog Number
- AB-2200
- Company Name
- DUNAMIS MEDICAL, LLC
- Labeler DUNS
- 079471560
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 2
- Public Version Date
- 2021-05-12
- Public Version Status
- Update
- Public Device Record Key
- a40bfa3c-41f3-4558-a783-3a19c784c2ab
Device Description
Dunamis Adjustable Fixation Button System
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
- No
- 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 |
|---|---|---|---|---|
| HTN | Washer, Bolt Nut | Orthopedic | 888.3030 | 2 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65038 | Orthopaedic fixation suture button | A small, implantable device designed to retain the loop of a ligature/suture to provide additional stability and accurate fixation during orthopaedic procedures, typically internal fixation of fractures with or without additional fixation devices (e.g., bone plates, screws). It can be of various shapes (e.g., H-shaped, round, oblong), made of non-bioabsorbable metallic materials [e.g., titanium (Ti)] and is typically implanted with dedicated implantation instruments; it may be supplied with associated sutures/ligatures. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00854629006697 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191319 | 000 |