FDA UDI
In Commercial Distribution
🇺🇸 United States
RADIANCE / R2 3.7 / 80W
DI: 04014501005101
·
Model: FR59 T12 80W PH / BiPin
·
NARVA Lichtquellen GmbH + Co KG.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- RADIANCE / R2 3.7 / 80W
- Primary DI
- 04014501005101
- Version / Model
- FR59 T12 80W PH / BiPin
- Catalog Number
- 27533
- Company Name
- NARVA Lichtquellen GmbH + Co KG.
- Labeler DUNS
- 330119702
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-24
- Public Version
- 2
- Public Version Date
- 2026-03-11
- Public Version Status
- Update
- Public Device Record Key
- 759b1da6-d752-424e-99ae-ea77f41289f7
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LEJ | Booth, Sun Tan | General, Plastic Surgery | 878.4635 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46387 | Ultraviolet tanning device | A mains electricity (AC-powered) lamp or bed/booth with lamps designed to provide radiation in the ultraviolet spectrum for tanning the skin. This device is used for cosmetic purposes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 54014501505101 | GS1 | Tertiary Packaging | 25 | In Commercial Distribution | |
| Primary | 04014501005101 | GS1 |
Customer Contacts
- Phone
- +1 781 331 0949
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry. Attention: Fragile.