Catalog Number

-

Brand Name

Parietex

Version/Model Number

PNP8X3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K101519,K101519

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Public Device Record Key

c0e29f8f-0268-43e4-b4cf-7f787954e763

Public Version Date

October 05, 2022

Public Version Number

11

DI Record Publish Date

October 22, 2015

Package DI Number

30884521176434

Quantity per Package

3

Contains DI Package

20884521176437

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK