Duns Number:532599255
Device Description: STP 4WAY RAD
Catalog Number
572488
Brand Name
STP 4WAY RAD
Version/Model Number
NA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 13, 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
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
K022895,K022895,K022895
Product Code
FMG
Product Code Name
Stopcock, I.V. Set
Public Device Record Key
2b4bb96d-7680-4466-96b3-2cda6bdc3b30
Public Version Date
November 02, 2020
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
27290102590029
Quantity per Package
6
Contains DI Package
17290102590022
Package Discontinue Date
May 13, 2018
Package Status
Not in Commercial Distribution
Package Type
Carton box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |