Kendall - 6x12 incision management dressing kit - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: 6x12 incision management dressing kit

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More Product Details

Catalog Number

49-6120SL

Brand Name

Kendall

Version/Model Number

49-6120SL

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

OMP

Product Code Name

negative pressure wound therapy Powered suction pump

Device Record Status

Public Device Record Key

8f5d3e9f-8a53-41f9-b7a1-4f66aae713d6

Public Version Date

March 18, 2022

Public Version Number

1

DI Record Publish Date

March 10, 2022

Additional Identifiers

Package DI Number

50885380165243

Quantity per Package

10

Contains DI Package

10885380165245

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