Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

HCT541BP-2

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

1296e68c-e073-4d18-b3a9-965ec2a3cf8a

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 16, 2018

Package DI Number

M752HCT541BP25

Quantity per Package

30

Contains DI Package

M752HCT541BP20

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box