Catalog Number

7091

Brand Name

PTFE Peelable Introducer Kit

Version/Model Number

10383-010

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"

-

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

8fe9556d-b300-453c-b924-cb3b1f7b7bf7

Public Version Date

June 07, 2019

Public Version Number

2

DI Record Publish Date

September 25, 2018

Package DI Number

10821329001212

Quantity per Package

1

Contains DI Package

00821329001215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box