Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

TM8516

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

b124027c-fd39-4b66-baa2-00b78379964f

Public Version Date

October 06, 2020

Public Version Number

3

DI Record Publish Date

September 06, 2019

Package DI Number

M752TM85165

Quantity per Package

20

Contains DI Package

M752TM85161

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer box