Duns Number:330119702
Catalog Number
23018
Brand Name
GOLDEN BRONZE / 140W / SM
Version/Model Number
FR59 T12 140W HO PH / BiPin
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 17, 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
180e084f-f22d-454d-8a1d-df9e6d2ef745
Public Version Date
September 19, 2018
Public Version Number
3
DI Record Publish Date
June 09, 2017
Package DI Number
84014501002069
Quantity per Package
24
Contains DI Package
54014501402066
Package Discontinue Date
September 17, 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 |