Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

RWM-DCT-SOR

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"

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

-

Product Code Name

-

Public Device Record Key

e59ac2e0-57b0-4c53-8bc7-9ff79c48f333

Public Version Date

November 08, 2018

Public Version Number

1

DI Record Publish Date

October 08, 2018

Package DI Number

M752RWMDCTSOR5

Quantity per Package

40

Contains DI Package

M752RWMDCTSOR0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box