Catalog Number

-

Brand Name

TiMESH

Version/Model Number

6000312

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

fa606046-b360-42ee-9dfc-9d5425b02c82

Public Version Date

October 21, 2020

Public Version Number

2

DI Record Publish Date

June 02, 2020

Package DI Number

04042301097613

Quantity per Package

3

Contains DI Package

04042301097606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box