FDA UDI
Not in Commercial Distribution
🇺🇸 United States
S.G 810
DI: 97640173080438
·
Model: 010916_1PC
·
Cendres+Métaux SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- S.G 810
- Primary DI
- 97640173080438
- Version / Model
- 010916_1PC
- Catalog Number
- 010916
- Company Name
- Cendres+Métaux SA
- Labeler DUNS
- 487506230
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-19
- Public Version
- 3
- Public Version Date
- 2021-05-10
- Public Version Status
- Update
- Public Device Record Key
- bdbe4b99-99e9-45ad-b062-4b0ae6b31875
- Distribution End Date
- 2020-08-24
Device Description
S.G 810
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
- Yes
- Sterilization Methods
- High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | Dental | 872.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38779 | Dental soldering alloy | A mixture of metals in the form of a thin rod used to solder cast dental restorations. It is a fusible alloy used to join less fusible materials (e.g., other metals, metal wires) through the application of high-temperature heat to the metal components to be joined; the soldering metal melts around the joint to create the fusion. The soldering process operates at lower termperatures than brazing. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 97640173080438 | GS1 |
Customer Contacts
- Phone
- +41583602000
- [email protected]