Duns Number:330119702
Catalog Number
10036
Brand Name
Cosmolux LS / 25W
Version/Model Number
F25 T5 25W PH / BiPin
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 13, 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
2cdfcf6a-7ae9-4ad1-b349-f067ed859ded
Public Version Date
August 14, 2018
Public Version Number
3
DI Record Publish Date
June 02, 2017
Package DI Number
54014501500014
Quantity per Package
25
Contains DI Package
04014501000014
Package Discontinue Date
August 13, 2018
Package Status
Not in Commercial Distribution
Package Type
Tertiary Packaging
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 446 |