Kangaroo - PEG Obturator - Cardinal Health, Inc.

Duns Number:080935429

Device Description: PEG Obturator

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More Product Details

Catalog Number

8884752208

Brand Name

Kangaroo

Version/Model Number

8884752208

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Record Status

Public Device Record Key

5871b99b-fce5-4e54-b9f2-9aa1c79ae0c8

Public Version Date

October 07, 2019

Public Version Number

8

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20884521007809

Quantity per Package

50

Contains DI Package

30884521007806

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 672
2 A medical device with a moderate to high risk that requires special controls. 1692
U Unclassified 17