Duns Number:330119702
Catalog Number
971646027
Brand Name
CLEO compact / 15W
Version/Model Number
F12 T5 15W 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
f49abaf8-db36-46ab-b86d-ba7efb75e7ec
Public Version Date
August 14, 2018
Public Version Number
3
DI Record Publish Date
June 09, 2017
Package DI Number
84014501003356
Quantity per Package
20
Contains DI Package
54014501503350
Package Discontinue Date
August 13, 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 |