Catalog Number

007977

Brand Name

Bard® PTFE Felt

Version/Model Number

007977

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

9ba649b3-64f0-4d08-b52c-bb2275858b86

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

September 25, 2015

Package DI Number

10801741041416

Quantity per Package

10

Contains DI Package

00801741041419

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA