Catalog Number

-

Brand Name

HERMESH

Version/Model Number

H30815

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

b77ba518-f4ef-4b46-93bf-e822ac8f480c

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

August 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-