FDA UDI
In Commercial Distribution
🇺🇸 United States
Gentle Pulse™
DI: 00810000520473
·
Model: D631GC
·
PARKELL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Gentle Pulse™
- Primary DI
- 00810000520473
- Version / Model
- D631GC
- Catalog Number
- D631GC
- Company Name
- PARKELL, INC.
- Labeler DUNS
- 009900424
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-14
- Public Version
- 3
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- ac577367-5bc8-4694-9113-fb476a19bee7
Device Description
Ground Clip and Lead Wire for Gentle Pulse™ & Digitest™ Pulptesters
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
- Yes
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| EAT | Tester, Pulp | Dental | 872.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13187 | 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810000520473 | GS1 | ||||
| Previous | M595D631GC0 | HIBCC |
Customer Contacts
- Phone
- 6312491134
- [email protected]