CARDINAL HEALTH - KIT,PROTECTOR INST LG XFIN ORG - CARDINAL HEALTH 200, LLC

Duns Number:112164780

Device Description: KIT,PROTECTOR INST LG XFIN ORG

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

HT9940919A

Brand Name

CARDINAL HEALTH

Version/Model Number

HT9940919A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 09, 2026

Issuing Agency

In GS1

Product Characteristics

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"

Yes

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 Details

Product Code

LRP

Product Code Name

TRAY, SURGICAL

Device Record Status

Public Device Record Key

26537e05-9b1b-49b3-a0d0-d515c2c51e8e

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

August 11, 2016

Additional Identifiers

Package DI Number

50885425107498

Quantity per Package

1

Contains DI Package

10885425107490

Package Discontinue Date

April 09, 2026

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH 200, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 81
2 A medical device with a moderate to high risk that requires special controls. 111