FDA UDI
In Commercial Distribution
🇺🇸 United States
Phasor Nosecones
DI: 10818207022155
·
Model: 408022
·
Vista Dental
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Phasor Nosecones
- Primary DI
- 10818207022155
- Version / Model
- 408022
- Company Name
- Vista Dental
- Labeler DUNS
- 036623932
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-01
- Public Version
- 1
- Public Version Date
- 2022-09-09
- Public Version Status
- New
- Public Device Record Key
- 242b710e-8ca0-4d66-9fce-32941d203e35
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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QGO | Composite Resin Warmer | Dental | 872.6100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65223 | Dental material heater | An electrically-powered device designed to be used to heat, through conduction, a variety of materials/substances (e.g., composite resin, root canal cleaning solution, local anaesthetic agent) to facilitate application of the material (e.g., optimum performance, patient comfort) during a dental procedure. It consists of a heating element with a temperature controller and a heater plate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10818207022155 | GS1 | ||||
| Direct Marking | 00818207022158 | GS1 |
Customer Contacts
- Phone
- 2626369755
- [email protected]