Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

RWM-DCT-LAM-IS

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

5f8d2f23-2af0-421c-86a5-5ea58002fc95

Public Version Date

October 29, 2018

Public Version Number

1

DI Record Publish Date

September 26, 2018

Package DI Number

M752RWMDCTLAMIS5

Quantity per Package

40

Contains DI Package

M752RWMDCTLAMIS0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box