Catalog Number

EC-0001-002

Brand Name

Biosensors Embolectomy Catheter

Version/Model Number

EL3280

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2020

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

-

Product Code

DXE

Product Code Name

Catheter, Embolectomy

Public Device Record Key

f2afd83e-d2b7-442d-855e-77667962c4d4

Public Version Date

October 24, 2022

Public Version Number

6

DI Record Publish Date

September 01, 2016

Package DI Number

58888893235108

Quantity per Package

30

Contains DI Package

08888893235103

Package Discontinue Date

December 01, 2020

Package Status

Not in Commercial Distribution

Package Type

CTN