CARDINAL HEALTH - Composite Dressing3.2 x 6 in.Superficial and - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Composite Dressing3.2 x 6 in.Superficial and non-infected wounds: -Post-operative wounds-S Composite Dressing3.2 x 6 in.Superficial and non-infected wounds: -Post-operative wounds-Skin grafts and donor sites-Lacerations and abrasions-Minor burns and scalds

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More Product Details

Catalog Number

COMP36

Brand Name

CARDINAL HEALTH

Version/Model Number

COMP36

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

NAC

Product Code Name

Dressing, wound, hydrophilic

Device Record Status

Public Device Record Key

2b592644-10f3-46a0-ab56-1b89109b0013

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

May 31, 2019

Additional Identifiers

Package DI Number

00888499000851

Quantity per Package

1

Contains DI Package

10885380064920

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"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