Catalog Number

-

Brand Name

TYRX™

Version/Model Number

CMRM6133

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180030

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Public Device Record Key

4a9db5fc-0737-4d94-aa66-d5cc8ae501f7

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

June 02, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-