Duns Number:600476669
Device Description: The Bendit®21 Microcatheter is intended for use in accessing target locations in the perip The Bendit®21 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices.Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.
Catalog Number
-
Brand Name
Bendit®21 Microcatheter
Version/Model Number
BDT21157U2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2050
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
K203842,K203842
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
000629eb-7efb-4412-af02-11bc5fdddc77
Public Version Date
June 17, 2022
Public Version Number
1
DI Record Publish Date
June 09, 2022
Package DI Number
27290018072046
Quantity per Package
1
Contains DI Package
17290018072049
Package Discontinue Date
December 31, 2050
Package Status
In Commercial Distribution
Package Type
Carton box