Duns Number:330119702
Device Description: UV - Tanning lamp, Accession # 102 0131-000 <CR> Exclusive distributor for USA: JW North A UV - Tanning lamp, Accession # 102 0131-000 <CR> Exclusive distributor for USA: JW North America, Inc., 233 Libbey Industrial Pkwy, Unit 2, Weymouth, MA 02189, Phone: +1 781 331 0949, Email: kapgar@jwnorthamerica.com <CR> Manufacturer: NARVA Lichtquellen GmbH + Co. KG, Industriegebiet Nord, Erzstrasse 22, 09618 Brand-Erbisdorf, Germany, Phone: +49 37322 17 200, Email: office@narva-bel.de, http://www.narva-bel.de
Catalog Number
9865 7174 0
Brand Name
CLEO SWIFT / 80W
Version/Model Number
FR59 T12 80W PH / BiPin
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 08, 2017
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
ae18851a-7f09-4a03-99fa-4b063fb8fe18
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 09, 2017
Package DI Number
84014501003387
Quantity per Package
20
Contains DI Package
54014501503381
Package Discontinue Date
December 08, 2017
Package Status
Not in Commercial Distribution
Package Type
Pallet
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 446 |