FDA UDI
In Commercial Distribution
🇺🇸 United States
White Electrosolder 2 DWT Protected Electrosolder
DI: 00841549100314
·
Model: 12445801
·
STERNGOLD DENTAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- White Electrosolder 2 DWT Protected Electrosolder
- Primary DI
- 00841549100314
- Version / Model
- 12445801
- Company Name
- STERNGOLD DENTAL LLC
- Labeler DUNS
- 124763728
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-02
- Public Version
- 3
- Public Version Date
- 2023-10-09
- Public Version Status
- Update
- Public Device Record Key
- 4bf66c89-ca76-4e99-afd2-991d1b9a79fd
Device Description
Specifically developed for electrosoldering, each laminated strip has solder on one side and pure gold on the other. The thickness of our 2 Dwt strip and its heavy gold layer prevent the bubbling and spitting sometimes encountered during electrosoldering procedures.
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| EJS | Alloy, Other Noble Metal | Dental | 872.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38780 | Dental brazing alloy | A mixture of metals, usually in the form of a thin rod, used to braze 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 brazing metal melts around the joint to create the fusion. The brazing process operates at higher temperatures than soldering. 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 | 00841549100314 | GS1 |
Customer Contacts
- Phone
- 5082265660
- [email protected]