Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

682-1775

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

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

69f932ad-9d45-4b48-8338-bcdb1da949df

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 02, 2017

Package DI Number

M75268217755

Quantity per Package

5

Contains DI Package

M75268217751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box