Catalog Number

INT-128-15

Brand Name

Tearaway Introducer Set

Version/Model Number

INT-128-15

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

c4e1b94b-fa09-4db5-906b-4d517f4c43cb

Public Version Date

April 27, 2022

Public Version Number

1

DI Record Publish Date

April 19, 2022

Package DI Number

10841268109763

Quantity per Package

10

Contains DI Package

00841268109766

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box