Duns Number:330119702
Catalog Number
31001
Brand Name
RIO Bronze
Version/Model Number
FR79T12 RIO Bronze SHR 2000 180W
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
33bf2bed-f45c-4ef1-9f06-632f11e7fe75
Public Version Date
June 04, 2018
Public Version Number
1
DI Record Publish Date
May 02, 2018
Package DI Number
84014501003974
Quantity per Package
24
Contains DI Package
54014501403988
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 |