DynaMesh - Hernia Mesh made of 100% Polyvinylidene Fluorid - FEG Textiltechnik Forschungs- und Entwicklungsges. mbH

Duns Number:341661031

Device Description: Hernia Mesh made of 100% Polyvinylidene Fluorid

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More Product Details

Catalog Number

PV231525F1

Brand Name

DynaMesh

Version/Model Number

VENTRAL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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 Details

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Device Record Status

Public Device Record Key

7f83c0e9-abaf-4587-8c58-b25c17f4d6c2

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

May 08, 2017

Additional Identifiers

Package DI Number

04250274705743

Quantity per Package

5

Contains DI Package

04250274705729

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box

"FEG TEXTILTECHNIK FORSCHUNGS- UND ENTWICKLUNGSGES. MBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 42