Duns Number:080580521
Device Description: Bashir™ S-B Endovascular Catheter 7Fr, 10.0cm basket
Catalog Number
7101
Brand Name
Bashir™ S-B Endovascular Catheter 7Fr, 10.0cm basket
Version/Model Number
7101
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
K192598,K192598
Product Code
KRA
Product Code Name
Catheter, Continuous Flush
Public Device Record Key
03704e23-3c49-43b8-bc13-87b84dcab6ba
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
February 17, 2020
Package DI Number
10850005115028
Quantity per Package
16
Contains DI Package
00850005115021
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |