Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

COTA-8136

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

0e758186-5770-460f-aba3-5621dc85f671

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

January 09, 2020

Package DI Number

M752COTA81365

Quantity per Package

20

Contains DI Package

M752COTA81361

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box