Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

HCT1CC-ST

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

ad35fb6b-6158-4a7f-9864-6eca07620038

Public Version Date

August 07, 2019

Public Version Number

1

DI Record Publish Date

July 30, 2019

Package DI Number

M752HCT1CCST5

Quantity per Package

5

Contains DI Package

M752HCT1CCST1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box