Duns Number:312827900
Device Description: UV - Tanning lamp, Accession # 0631196-001<CR> Exclusive distributor for USA: HN Sunlight 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, info@original-hanau.com, http://www.original-hanau.com<CR> Manufacturer: G.L.E. Gesellschaft für lichttechnische Erzeugnisse mbH, Herzbergstraße 26, 10365 Berlin, Germany, Phone: +49 30 5576 6-0, info@narva-gle.com, http://www.narva-gle.com
Catalog Number
8002 1517
Brand Name
Original Hanau
Version/Model Number
Strahler OH M 60/80 EF
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LEJ
Product Code Name
Booth, Sun Tan
Public Device Record Key
a4bb0c87-40e8-4826-b684-a6fa7c2c2a67
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 01, 2016
Package DI Number
54054657600268
Quantity per Package
100
Contains DI Package
14054657500263
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CaseTertiary 100x
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |