Catalog Number

-

Brand Name

HERMESH

Version/Model Number

H40611

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

K973955,K973955

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Public Device Record Key

8c435f1b-6494-42d8-9692-91b9cfe8ffeb

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

August 02, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-