Catalog Number

KLRH007-12

Brand Name

Halyard

Version/Model Number

KLRH007-12_0008

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

Yes

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

49ca5d0a-d976-4e83-9e2c-7a61f5540d56

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Package DI Number

20809160388126

Quantity per Package

3

Contains DI Package

10809160388129

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-