Duns Number:058716649
Device Description: Stellant Dual 200mL Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (STLNT,KI Stellant Dual 200mL Syringe Kit with LPDCT with T-Connector and 2 sterile spikes (STLNT,KIT,SYR,CT,D,SPK,FLS3,200ML,RW) (85071041)
Catalog Number
FLEXD-200-SPK
Brand Name
MEDRAD® Stellant FLEX Syringe Kit
Version/Model Number
FLEXD-200-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
K173773,K173773,K173773,K173773
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
cb6641b3-ac2f-472e-96c2-9c9c162cc9aa
Public Version Date
December 24, 2018
Public Version Number
1
DI Record Publish Date
November 22, 2018
Package DI Number
70616258010624
Quantity per Package
600
Contains DI Package
00616258010625
Package Discontinue Date
December 31, 9999
Package Status
In Commercial Distribution
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 |