Catalog Number

-

Brand Name

Parietene DS

Version/Model Number

PPDS15X3

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

K163212,K163212

Product Code

FTL

Product Code Name

Mesh, surgical, polymeric

Public Device Record Key

7bac455e-9b6b-4270-a9b3-918eeabdeddf

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

December 15, 2017

Package DI Number

20884521553542

Quantity per Package

3

Contains DI Package

10884521553545

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK