FDA UDI
In Commercial Distribution
🇺🇸 United States
TOUCH® CMC 1
DI: 07640181160037
·
Model: NTO010
·
Keri Medical SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TOUCH® CMC 1
- Primary DI
- 07640181160037
- Version / Model
- NTO010
- Company Name
- Keri Medical SA
- Labeler DUNS
- 480138827
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-18
- Public Version
- 2
- Public Version Date
- 2026-03-05
- Public Version Status
- Update
- Public Device Record Key
- a7917c87-8d33-4556-a216-31fad6de9809
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| SFA | Prosthesis, Finger, Semi-Constrained, Metal/Polymer | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40126 | Metacarpal prosthesis | A sterile implantable device designed to replace the proximal end (base) of the first metacarpal of the thumb carpometacarpal (CMC) joint (articulation with the trapezium) typically to treat thumb instability/motion disabilities caused by arthritis or fracture. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal); implantation may be performed with our without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640181160037 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P240020 | 000 |