Catalog Number

-

Brand Name

Parietex

Version/Model Number

PCO8VP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 21, 2016

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

K120506,K142908

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Public Device Record Key

f912193d-c05f-4a79-962b-3c4d83116cf6

Public Version Date

October 25, 2022

Public Version Number

11

DI Record Publish Date

October 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-