Catalog Number

-

Brand Name

SurgiMesh

Version/Model Number

Tintra CK-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120025

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

202706dc-07df-469c-a94c-a893ce736a06

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

January 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-