Catalog Number

007835

Brand Name

Bard® Edwards Outflow Tract Knitted PTFE Fabric

Version/Model Number

007835

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

-

Product Code

DXZ

Product Code Name

PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Public Device Record Key

a972283f-11d1-46b7-9b1b-2e60a71a74e4

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

September 25, 2015

Package DI Number

10801741041096

Quantity per Package

5

Contains DI Package

00801741041099

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA