Duns Number:330119702
Device Description: UV - Tanning lamp, Accession # 122 0531-000 <CR> Exclusive distributor for USA: JW North UV - Tanning lamp, Accession # 122 0531-000 <CR> Exclusive distributor for USA: JW North America, Inc., 233 Libbey Industrial Pkwy 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
901935140
Brand Name
Ergoline SR Super Power
Version/Model Number
FR71T12 100W-R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 14, 2018
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
7b99514f-290a-4454-9378-af9e5d9e2321
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 21, 2017
Package DI Number
84014501003486
Quantity per Package
24
Contains DI Package
54014501403483
Package Discontinue Date
February 14, 2018
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 |