CARDINAL HEALTH - Kidney Stone Transportation Box Kit - Aero-Med, Ltd.

Duns Number:194550042

Device Description: Kidney Stone Transportation Box Kit

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More Product Details

Catalog Number

LCA290

Brand Name

CARDINAL HEALTH

Version/Model Number

LCA290

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)

-

Over the Counter (OTC)

Yes

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

16cfc741-bec9-4cb6-bc51-ad2d6af0b4bf

Public Version Date

August 26, 2019

Public Version Number

1

DI Record Publish Date

August 16, 2019

Additional Identifiers

Package DI Number

50810010892268

Quantity per Package

12

Contains DI Package

00810010892263

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"AERO-MED, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 467
2 A medical device with a moderate to high risk that requires special controls. 14