Catalog Number

AHEX25M

Brand Name

Halyard

Version/Model Number

AHEX25M_0005

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

LRO

Product Code Name

General surgery tray

Public Device Record Key

10cd5b5e-8ad6-41fa-8384-0b4defe142a8

Public Version Date

October 25, 2022

Public Version Number

1

DI Record Publish Date

October 17, 2022

Package DI Number

20809160387792

Quantity per Package

5

Contains DI Package

10809160387795

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-