Duns Number:058716649
Device Description: STLNT,KIT,SYR,CT,S,SPK,FLS3,200ML,WLD (87078744)
Catalog Number
FLEXS-200-SPK
Brand Name
MEDRAD® Stellant FLEX Syringe Kit
Version/Model Number
FLEXS-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
Product Code
DXT
Product Code Name
Injector And Syringe, Angiographic
Public Device Record Key
00f1d714-fd4a-48f2-813c-ea14803926a7
Public Version Date
January 01, 2020
Public Version Number
1
DI Record Publish Date
December 24, 2019
Package DI Number
40616258022824
Quantity per Package
50
Contains DI Package
00616258022826
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 |