Catalog Number

INT-109-12

Brand Name

Tearaway Introducer Set

Version/Model Number

INT-109-12

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 14, 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"

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

-

Product Code

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

72fcbf15-029a-44e6-8cc9-cb69746dfa22

Public Version Date

December 15, 2020

Public Version Number

4

DI Record Publish Date

January 19, 2017

Package DI Number

10841268100081

Quantity per Package

1

Contains DI Package

00841268100084

Package Discontinue Date

December 14, 2020

Package Status

Not in Commercial Distribution

Package Type

Shelf Box