FDA UDI
In Commercial Distribution
🇺🇸 United States
NUPRO®
DI: D0039652511
·
Model: 965251
·
Dentsply Professional
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1200
Basic Information
- Brand Name
- NUPRO®
- Primary DI
- D0039652511
- Version / Model
- 965251
- Catalog Number
- 965251
- Company Name
- Dentsply Professional
- Labeler DUNS
- 144140845
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1200
- Record Status
- Published
- Publish Date
- 2022-11-24
- Public Version
- 1
- Public Version Date
- 2022-12-02
- Public Version Status
- New
- Public Device Record Key
- 46f6f6bb-a887-4827-b46f-41939f5a6658
Device Description
NUPRO® revolv® Disposable Prophy Angle, Soft Cup, Econo box 1200
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
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGS | Handpiece, contra- and right-angle attachment, dental | Dental | 872.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46938 | Dental polishing cup, single-use | A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D0039652510 | HIBCC | ||||
| Primary | D0039652511 | HIBCC |