Vitality Scanner
- Primary DI
- 00195062011122
- Brand
- Vitality Scanner
- Company
- Kerr Corporation
- Model
- 973-0227
- Device description
- LIP CLIP
- Published
- 2021-03-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EAT | Tester, Pulp | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00195062030093 | Primary | GS1 | 0 | |
| 00195062011122 | Unit of Use | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00195062030093 | 00195062030093 | 195062030093 | 0195062030093 |
| 00195062011122 | 00195062011122 | 195062011122 | 0195062011122 |
GMDN Terms
| Term | Definition |
|---|
| Dental pulp analysis system | An assembly of devices designed to evaluate the pulpal vitality of teeth by electrically stimulating the nerve tissue of the pulp. The electric current needed to obtain a patient response to the stimulus is a measure of the condition of the dental pulp. The system typically includes a high frequency electronic oscillator, cables, and electrodes to apply the electrical signal; a display may be included. The system is used for determination of pulp necrosis, pulpitis, and involvement of teeth that approximate lesions (i.e., teeth that are next to diseased tissue). |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 199354556
- Device count
- 5
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
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| D79659701 | MARK3 | CARGUS INTERNATIONAL, INC | EAT | 2021-10-04 |
| 00195062030086 | Vitality Scanner | Kerr Corporation | EAT | 2021-03-05 |
| 00195062011139 | Vitality Scanner | Kerr Corporation | EAT | 2021-03-05 |
| 00195062011146 | Vitality Scanner | Kerr Corporation | EAT | 2021-03-05 |
| 00195062011153 | Vitality Scanner | Kerr Corporation | EAT | 2021-03-05 |
| 00195062030130 | Touch 'n Heat | Kerr Corporation | EAT | 2021-03-05 |
| 00195062030970 | Lead Cord | Kerr Corporation | EAT | 2021-03-05 |
| 00195062030987 | File Clip | Kerr Corporation | EAT | 2021-03-05 |
| 00195062031021 | Elements | Kerr Corporation | EAT | 2021-03-05 |
| 00195062031038 | Satellite with Satellite Cord | Kerr Corporation | EAT | 2021-03-05 |
| 00195062031045 | Elements | Kerr Corporation | EAT | 2021-03-05 |
| 00195062030963 | Lip Hook | Kerr Corporation | EAT | 2021-03-05 |