Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

HCT300N-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

-

Product Code Name

-

Public Device Record Key

f8b1ff58-71cc-43e2-871e-ea8944e4c3fb

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 16, 2018

Package DI Number

M752HCT300N25

Quantity per Package

30

Contains DI Package

M752HCT300N20

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box