FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Power Dental U.S.A., Inc.
DI: D943N7643
·
Model: N7643
·
Power Dental U.S.A. Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Power Dental U.S.A., Inc.
- Primary DI
- D943N7643
- Version / Model
- N7643
- Catalog Number
- N7643
- Company Name
- Power Dental U.S.A. Inc.
- Labeler DUNS
- 081305064
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-20
- Public Version
- 4
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- e24df945-610a-4f09-a86b-4787e77355c9
- Distribution End Date
- 2022-06-17
Device Description
HANDPIECE POLISHING TIPS 6 TIPS WITH CASSETTE
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| FSM | TRAY, SURGICAL, INSTRUMENT | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12143 | Instrument tray, reusable | A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D943N7643 | HIBCC |
Customer Contacts
- Phone
- +1(815)363-8003
- [email protected]