Duns Number:330119702
Catalog Number
12601
Brand Name
COSMOLUX ESP / 100W
Version/Model Number
F73 T12 100W RS / RDC
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 14, 2020
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
df15dfd1-943e-4d92-901d-0deb527a7dc2
Public Version Date
October 16, 2020
Public Version Number
3
DI Record Publish Date
June 09, 2017
Package DI Number
84014501000300
Quantity per Package
24
Contains DI Package
54014501400307
Package Discontinue Date
October 14, 2020
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 |