Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

TMDCIP3

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

415a2215-dd4b-4033-9f33-251b4d122cf8

Public Version Date

May 01, 2019

Public Version Number

1

DI Record Publish Date

April 23, 2019

Package DI Number

M752TMDCIP35

Quantity per Package

30

Contains DI Package

M752TMDCIP30

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box