FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Stainless Steel Wire
DI: D001N0810180
·
Model: 18 Gauge
·
Dentsply International Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Stainless Steel Wire
- Primary DI
- D001N0810180
- Version / Model
- 18 Gauge
- Catalog Number
- N081018
- Company Name
- Dentsply International Inc.
- Labeler DUNS
- 606173334
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2018-09-19
- Public Version
- 4
- Public Version Date
- 2022-05-24
- Public Version Status
- Update
- Public Device Record Key
- f8cc38ca-99a9-45e6-ab27-597dd7d6a304
- Distribution End Date
- 2022-05-23
Device Description
Round 10ft
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| DZC | WIRE, ORTHODONTIC | Dental | 872.5410 | 1 |
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 | D001N0810180 | HIBCC | ||||
| Unit of Use | D001N0810188 | HIBCC |
Customer Contacts
- Phone
- +1(800)243-1942 ext. 54660
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Feet |