Duns Number:529174252
Device Description: 1-21" Swabable valve Transfer set
Catalog Number
ST-1304
Brand Name
Steriatrics
Version/Model Number
700107-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 9999
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
1300ca5b-6c58-4233-b552-539bc9765691
Public Version Date
September 15, 2020
Public Version Number
1
DI Record Publish Date
September 07, 2020
Package DI Number
16938327904521
Quantity per Package
50
Contains DI Package
06938327904524
Package Discontinue Date
September 07, 2020
Package Status
Not in Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 183 |