Plug T5 - T5 cm 6,5x10 is a semirigid pre-shaped mesh with - HERNIAMESH SRL

Duns Number:459310140

Device Description: T5 cm 6,5x10 is a semirigid pre-shaped mesh with eccentric hole knitted with Polypropylene T5 cm 6,5x10 is a semirigid pre-shaped mesh with eccentric hole knitted with Polypropylene monofilament, indicated for use in inguinal hernia repairs when there is a significant destruction or weakness of the posterior wall.

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More Product Details

Catalog Number

-

Brand Name

Plug T5

Version/Model Number

PT50-S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 14, 2021

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

f1d02936-0fe4-40d9-9001-f287f24ac7dd

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

January 08, 2018

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