FDA UDI
In Commercial Distribution
🇺🇸 United States
Classic
DI: B77202590
·
Model: 36 Syringe Bulk Pack
·
NU RADIANCE INC
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Classic
- Primary DI
- B77202590
- Version / Model
- 36 Syringe Bulk Pack
- Catalog Number
- 0259
- Company Name
- NU RADIANCE INC
- Labeler DUNS
- 148149243
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-17
- Public Version
- 1
- Public Version Date
- 2021-08-25
- Public Version Status
- New
- Public Device Record Key
- e63b2ed2-6234-4305-98d0-9b7d67b76d16
Device Description
Nu Radiance Classic Teeth Whitening, 16% Carbamide Peroxide, 36 Syringe Bulk Pack
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46432 | Teeth whitening kit | A collection of devices intended to whiten natural teeth through bleaching. It typically includes a bleaching agent (e.g., a gel containing a low concentration of an oxidizing agent, such as carbamide peroxide or hydrogen peroxide), a syringe(s), a tray(s), a mouthguard, an applicator (e.g., a brush) and strips to apply/retain the bleaching agent to/on the teeth for a recommended period. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B77202590 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 72 Degrees Fahrenheit