FDA UDI
In Commercial Distribution
🇺🇸 United States
Plasdent
DI: D832RRA1
·
Model: RR-A
·
PLASDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- Plasdent
- Primary DI
- D832RRA1
- Version / Model
- RR-A
- Catalog Number
- RR-A
- Company Name
- PLASDENT CORPORATION
- Labeler DUNS
- 190377184
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2022-01-28
- Public Version
- 1
- Public Version Date
- 2022-02-07
- Public Version Status
- New
- Public Device Record Key
- aa00997b-935f-46c1-a9cd-3986d1839d88
Device Description
Retainer Retriever, Assorted
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| NRD | Unit, Operative Dental, Accessories | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63677 | Orthodontic appliance remover | A small hook-shaped device designed for manual removal of orthodontic devices (e.g., retainer, teeth positioner) from around the teeth. It is made of plastic materials. This is a single-patient, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D832RRA0 | HIBCC | ||||
| Primary | D832RRA1 | HIBCC |