Duns Number:330119702
Catalog Number
26503
Brand Name
Cosmolux Lynx K1
Version/Model Number
FR75 T12 180-200W SM
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
7d6bab2d-5362-437a-a35a-4f69dbd6f686
Public Version Date
July 25, 2019
Public Version Number
1
DI Record Publish Date
July 17, 2019
Package DI Number
54014501404121
Quantity per Package
24
Contains DI Package
04014501004128
Package Discontinue Date
-
Package Status
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 |