FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HNI
DI: 04054657500075
·
Model: Strahler HNI 765 F (BQ 765 Z4 F)
·
G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- HNI
- Primary DI
- 04054657500075
- Version / Model
- Strahler HNI 765 F (BQ 765 Z4 F)
- Catalog Number
- 4500 6417
- Company Name
- G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
- Labeler DUNS
- 312827900
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-28
- Public Version
- 3
- Public Version Date
- 2020-01-28
- Public Version Status
- Update
- Public Device Record Key
- dd026ff9-f1c6-4066-96c1-16e4f55e2561
- Distribution End Date
- 2020-01-27
Device Description
UV - Tanning lamp, Accession # 0631196-001 <CR> Exclusive distributor for USA: HN Sunlight GmbH, Original Hanau, Kurt-Blaum-Platz 2, 63450 Hanau, Germany, Phone: +49 6181 490 23 16, [email protected], http://www.original-hanau.com <CR> Manufacturer: NARVA G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH, Herzbergstraße 26, 10365 Berlin, Germany, Phone: +49 30 5576 6-0, [email protected], http://www.narva-gle.com
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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 04054657500075 | GS1 | ||||
| Package | 14054657500072 | GS1 | SecondaryPackaging | 1 | Not in Commercial Distribution | 2020-01-27 |
| Package | 54054657600077 | GS1 | CaseTertiary 100x | 100 | Not in Commercial Distribution | 2020-01-27 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry