Catalog Number

082238

Brand Name

Bard® Guidewires

Version/Model Number

082238

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

EZB

Product Code Name

STYLET FOR CATHETER, GASTRO-UROLOGY

Public Device Record Key

35b7ba36-06a2-4703-a337-575b510885dd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 28, 2017

Package DI Number

10801741052863

Quantity per Package

10

Contains DI Package

00801741052866

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA