FDA UDI
In Commercial Distribution
🇺🇸 United States
PerfectPearl Classic
DI: 00615375004036
·
Model: 10-9514
·
METREX RESEARCH, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
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Basic Information
- Brand Name
- PerfectPearl Classic
- Primary DI
- 00615375004036
- Version / Model
- 10-9514
- Company Name
- METREX RESEARCH, LLC
- Labeler DUNS
- 145963778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 36988f08-f6b2-4e1c-ada7-9f25d83f8954
Device Description
Disposable Prophy Contra Angles Blue Shell Dark Blue Pad Soft Cup
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EHL | POINT, ABRASIVE | Dental | 872.6010 | 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 |
|---|---|---|---|---|---|---|
| Secondary | D68310951405 | HIBCC | ||||
| Primary | 00615375004036 | GS1 | ||||
| Unit of Use | 00615375007044 | GS1 |
Customer Contacts
- Phone
- +18008411428
- [email protected]