Catalog Number

PP1715/B

Brand Name

Coaxial Introducer

Version/Model Number

10884450443146

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GDF

Product Code Name

GUIDE, NEEDLE, SURGICAL

Public Device Record Key

9d15ef34-0077-431a-9d76-e9cbaaa316c9

Public Version Date

May 11, 2021

Public Version Number

1

DI Record Publish Date

May 03, 2021

Package DI Number

20884450443143

Quantity per Package

18

Contains DI Package

10884450443146

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-