Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

IM1259

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

5a08c1d8-5e91-4e88-8d07-9e0672dd271f

Public Version Date

April 25, 2019

Public Version Number

2

DI Record Publish Date

March 26, 2019

Package DI Number

M752IM12595

Quantity per Package

20

Contains DI Package

M752IM12590

Package Discontinue Date

April 23, 2019

Package Status

Not in Commercial Distribution

Package Type

outer box