Duns Number:330119702
Catalog Number
16180
Brand Name
COSMOLUX VHR / 160W
Version/Model Number
FR71 T12 160W VHO PH / BiPin
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 17, 2019
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
5b33a4f8-fafb-4efa-9134-cb11f707e0e1
Public Version Date
November 19, 2019
Public Version Number
3
DI Record Publish Date
June 09, 2017
Package DI Number
84014501000577
Quantity per Package
24
Contains DI Package
54014501400574
Package Discontinue Date
November 17, 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 |