Catalog Number

98432-03

Brand Name

Halyard

Version/Model Number

98432

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

KGC

Product Code Name

TUBE, GASTRO-ENTEROSTOMY

Public Device Record Key

15aafdf3-61a8-4a71-b663-e3eef5d28fb3

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

July 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-