FDA UDI
In Commercial Distribution
🇺🇸 United States
Retainer Retriever
DI: D746RR1TSB1
·
Model: RR-1TSB
·
DENTSPLY SIRONA ORTHODONTICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Retainer Retriever
- Primary DI
- D746RR1TSB1
- Version / Model
- RR-1TSB
- Catalog Number
- RR-1TSB
- Company Name
- DENTSPLY SIRONA ORTHODONTICS INC.
- Labeler DUNS
- 116903307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2021-12-22
- Public Version
- 1
- Public Version Date
- 2021-12-30
- Public Version Status
- New
- Public Device Record Key
- b80ea889-66f3-4944-94da-5d1098ab192a
Device Description
RETAINER RETRIEVER - TROPICAL BLUE 10PK
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| ECR | Setter, Band, Orthodontic | Dental | 872.4565 | 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 | D746RR1TSB0 | HIBCC | ||||
| Primary | D746RR1TSB1 | HIBCC |