LEADER - Antibacterial Sheer Adhesive Bandages; Helps - Cardinal Health 110, Inc.

Duns Number:063997360

Device Description: Antibacterial Sheer Adhesive Bandages; Helps Prevent Infection; Invisible Protection; High Antibacterial Sheer Adhesive Bandages; Helps Prevent Infection; Invisible Protection; Highly Absorbent Non-Stick Pad; Long Lasting; Sterile Bandages; Active Ingredient: Benzalkonium Chloride 0.1 percent; All One Size 7/8 IN.

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More Product Details

Catalog Number

5084611

Brand Name

LEADER

Version/Model Number

5084611

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)

-

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

KGX

Product Code Name

Tape and bandage, adhesive

Device Record Status

Public Device Record Key

d65eefd0-b067-4fcc-9348-22b2281cbf50

Public Version Date

July 02, 2021

Public Version Number

3

DI Record Publish Date

April 18, 2019

Additional Identifiers

Package DI Number

50096295126940

Quantity per Package

24

Contains DI Package

00096295126945

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH 110, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 39