Duns Number:330119702
Catalog Number
971036940
Brand Name
CLEO ADVANTAGE / 100W
Version/Model Number
FR71 T12 100W 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
085b3eca-31b6-4c95-a71e-024c363314b7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 09, 2017
Package DI Number
84014501003349
Quantity per Package
20
Contains DI Package
54014501503343
Package Discontinue Date
-
Package Status
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 |