CARDINAL HEALTH - PERC NEPHRO LITHO - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: PERC NEPHRO LITHO

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More Product Details

Catalog Number

SBA11PNCHB

Brand Name

CARDINAL HEALTH

Version/Model Number

SBA11PNCHB

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"

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

PPE

Product Code Name

Nephroscope set

Device Record Status

Public Device Record Key

f5f3575d-ef10-4503-ab57-a284b59d8eea

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 05, 2018

Additional Identifiers

Package DI Number

50888439114865

Quantity per Package

2

Contains DI Package

10888439114867

Package Discontinue Date

-

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 101686
2 A medical device with a moderate to high risk that requires special controls. 139430
3 A medical device with high risk that requires premarket approval 8
U Unclassified 40