HERMESH - Hermesh 6 cm 8x15 is a rectangular light - HERNIAMESH SRL

Duns Number:459310140

Device Description: Hermesh 6 cm 8x15 is a rectangular light macroporous mesh knitted with Polypropylene monof Hermesh 6 cm 8x15 is a rectangular light macroporous mesh knitted with Polypropylene monofilament, indicated for bothopen and laparoscopic hernia repair.

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More Product Details

Catalog Number

-

Brand Name

HERMESH

Version/Model Number

H60815

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Device Record Status

Public Device Record Key

4e4c30a8-f12c-4743-9901-4c678f1299cb

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

August 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HERNIAMESH SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14