Duns Number:058716649
Device Description: Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(KIT,SYR,STLNT Stellant Single Syringe Kit with LPDCT with T-Connector and 2 sterile spikes(KIT,SYR,STLNT,APOLLO,W/LPCT,SPK, MC, LA)(60728826)
Catalog Number
SSS-CTP-SPK
Brand Name
MEDRAD® Stellant Sterile Disposable Syringe
Version/Model Number
SSS-CTP-SPK
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"
Yes
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
K023183
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
3c8df7b8-663a-4d6b-9029-88b6922ae741
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 360 |