Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

TMCLK-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

fa8e1e14-97c4-4f8e-9f70-7949f47a4cae

Public Version Date

April 21, 2021

Public Version Number

1

DI Record Publish Date

April 13, 2021

Package DI Number

M752TMCLK25

Quantity per Package

30

Contains DI Package

M752TMCLK20

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Box