Duns Number:330119702
Catalog Number
32543 /3230076173
Brand Name
extraSunlight
Version/Model Number
FRW68T12 / extraSunlight 1711R / 200W
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
e8d01435-4f56-426d-bfc3-f86aff6f4a25
Public Version Date
April 14, 2022
Public Version Number
1
DI Record Publish Date
April 06, 2022
Package DI Number
54014501304667
Quantity per Package
6
Contains DI Package
04014501004661
Package Discontinue Date
April 06, 2022
Package Status
Not in Commercial Distribution
Package Type
Tertiary Packacking
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 446 |