FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: M595D6360
·
Model: D636
·
PARKELL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- M595D6360
- Version / Model
- D636
- Catalog Number
- D636
- Company Name
- PARKELL, INC.
- Labeler DUNS
- 009900424
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-09-11
- Public Version Status
- Update
- Public Device Record Key
- ddbf1e14-a3c8-4279-a267-d3c45e721bf1
- Distribution End Date
- 2018-09-10
Device Description
Precision Probe Set for Gentle Pulse™ & Digitest™ Pulptesters (1-each Facial & Lingual Probes)
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
- No
- 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 | M595D6360 | HIBCC |
Customer Contacts
- Phone
- 6312491134
- [email protected]