FDA UDI
In Commercial Distribution
🇺🇸 United States
Prophy Rubber Cup
DI: 08806383525855
·
Model: Umbrella Shape, Latch Type
·
DiaDent Group International
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Prophy Rubber Cup
- Primary DI
- 08806383525855
- Version / Model
- Umbrella Shape, Latch Type
- Catalog Number
- 950-231
- Company Name
- DiaDent Group International
- Labeler DUNS
- 687789453
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-13
- Public Version
- 1
- Public Version Date
- 2020-08-21
- Public Version Status
- New
- Public Device Record Key
- 31eb9ae3-d089-42e3-97ac-c263a024bb27
Device Description
A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning).
Device Characteristics
- Single Use
- Yes
- 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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EHK | Cup, Prophylaxis | Dental | 872.6290 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64015 | Dental-professional prophylaxis brush, single-use | A non-sterile rotary dental instrument with natural or synthetic bristle brushes intended to be used by a dental hygienist and/or dentist to clean and polish teeth. It is designed to be attached to a powered dental handpiece which provides the necessary rotation. This is a single-use device. | No | Active |
| 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 |
|---|---|---|---|---|---|---|
| Primary | 08806383525855 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry and Keep away from Sunlight.