Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 10.0cm Infusion - Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm - THROMBOLEX, INC.

Duns Number:080580521

Device Description: Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 10.0cm Infusion

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More Product Details

Catalog Number

7210

Brand Name

Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 10.0cm Infusion

Version/Model Number

7210

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K193071,K193071

Product Code Details

Product Code

KRA

Product Code Name

Catheter, Continuous Flush

Device Record Status

Public Device Record Key

6885229c-7b86-4bce-be82-490df391e82c

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

February 17, 2020

Additional Identifiers

Package DI Number

10850005115035

Quantity per Package

16

Contains DI Package

00850005115038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"THROMBOLEX, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1