Catalog Number

-

Brand Name

Parietex

Version/Model Number

PCO2015OSX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K110816

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Public Device Record Key

c4e2c12f-946d-43e0-ae22-61a229afc58a

Public Version Date

October 25, 2022

Public Version Number

9

DI Record Publish Date

October 06, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-