Catalog Number

KIT-064-12

Brand Name

Tearaway Introducer Kit

Version/Model Number

KIT-064-12

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

OFL

Product Code Name

Percutaneous Sheath Introducer Kit

Public Device Record Key

1493137b-0f46-4d51-9827-ae6be86fa5d7

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

February 06, 2018

Package DI Number

20841268100064

Quantity per Package

50

Contains DI Package

10841268100067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box