Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

525-038 R1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

OFL

Product Code Name

Percutaneous Sheath Introducer Kit

Public Device Record Key

52cff24c-f20a-4d4f-a2d1-a68afe7bcdf3

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

April 12, 2017

Package DI Number

M752525038R13

Quantity per Package

5

Contains DI Package

M752525038R10

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner carton