FDA UDI
In Commercial Distribution
🇺🇸 United States
HNI
DI: 04054657500501
·
Model: Strahler HNI 468 S (BQ 468 z4)
·
G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- HNI
- Primary DI
- 04054657500501
- Version / Model
- Strahler HNI 468 S (BQ 468 z4)
- Catalog Number
- 4500 6489
- Company Name
- G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH
- Labeler DUNS
- 312827900
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-28
- Public Version
- 3
- Public Version Date
- 2020-03-18
- Public Version Status
- Update
- Public Device Record Key
- bbac2e36-112a-48f8-9dfb-e852a3574699
Device Description
UV - Tanning lamp
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
- 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 | 04054657500501 | GS1 | ||||
| Package | 14054657500508 | GS1 | SecondaryPackaging | 1 | In Commercial Distribution | |
| Package | 54054657600503 | GS1 | CaseTertiary 100x | 100 | In Commercial Distribution |
Customer Contacts
- Phone
- +4961814902316
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151674 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry