Duns Number:330119702
Catalog Number
21069
Brand Name
Radiance / 25W
Version/Model Number
F25 T5 25W PH / BiPin
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
59a70c6b-88e8-4996-9e25-f1d1dd616e66
Public Version Date
December 12, 2019
Public Version Number
2
DI Record Publish Date
February 04, 2019
Package DI Number
84014501004087
Quantity per Package
20
Contains DI Package
54014501404084
Package Discontinue Date
December 10, 2019
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 |