Catalog Number

C-PRG-20D

Brand Name

Biodesign

Version/Model Number

G56580

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 18, 2017

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133011

Product Code

OWV

Product Code Name

Mesh, surgical, collagen, diaphragmatic hernia

Public Device Record Key

678016c7-e69d-4700-b140-cb5195d2c810

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

November 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-