HERMESH - Hermesh 4 cm 15x15 is a square macroporous mesh - HERNIAMESH SRL

Duns Number:459310140

Device Description: Hermesh 4 cm 15x15 is a square macroporous mesh with bi-directional elasticity, knitted wi Hermesh 4 cm 15x15 is a square macroporous mesh with bi-directional elasticity, knitted with Polypropylene monofilament, indicated for both open and laparoscopic hernia repair

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More Product Details

Catalog Number

-

Brand Name

HERMESH

Version/Model Number

H41515

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

d8adf4fb-1bfe-46f7-b80a-d95c947dc04f

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

August 03, 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