FDA UDI
In Commercial Distribution
🇺🇸 United States
CM LOC®
DI: 07640166511298
·
Model: 07000213
·
Cendres+Métaux SA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- CM LOC®
- Primary DI
- 07640166511298
- Version / Model
- 07000213
- Catalog Number
- 07000213
- Company Name
- Cendres+Métaux SA
- Labeler DUNS
- 487506230
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2019-04-01
- Public Version
- 3
- Public Version Date
- 2021-09-24
- Public Version Status
- Update
- Public Device Record Key
- 4f97d4f0-f688-42a2-80e1-846949687a13
Device Description
CM LOC® Impression part
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64323 | Dental implant abutment impression cap | A small device intended to be placed intraorally on the abutment head of a dental implant during a dental impression to facilitate removal of the impression material once it has hardened, and to reproduce the intraoral position and orientation of the abutment/implant in a dental laboratory working model, for the fabrication of a final dental prosthesis (e.g., denture). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640166511298 | GS1 | ||||
| Unit of Use | 07640239931947 | GS1 |
Customer Contacts
- Phone
- +41583602000
- [email protected]