Duns Number:600476669
Device Description: The Bendit2.7™ Steerable Microcatheter is intended for general intravascular use in the pe The Bendit2.7™ Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic, or therapeutic materials into the vasculature.
Catalog Number
-
Brand Name
Bendit2.7 Steerable Microcatheter
Version/Model Number
BDT01200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
August 24, 2050
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K200582,K200582,K200582,K200582,K200582
Product Code
KRA
Product Code Name
Catheter, Continuous Flush
Public Device Record Key
b1b6d21d-e948-46c0-9e97-d6217d549e5e
Public Version Date
September 01, 2020
Public Version Number
1
DI Record Publish Date
August 24, 2020
Package DI Number
27290018072008
Quantity per Package
1
Contains DI Package
17290018072001
Package Discontinue Date
December 31, 2030
Package Status
In Commercial Distribution
Package Type
-