Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

RWM-DLH138-LS

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

MCY

Product Code Name

Wound Dressing Kit

Public Device Record Key

5f99f494-75cf-4b48-87da-5a5cd2e74399

Public Version Date

January 07, 2019

Public Version Number

1

DI Record Publish Date

December 07, 2018

Package DI Number

M752RWMDLH138LS5

Quantity per Package

30

Contains DI Package

M752RWMDLH138LS0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box