CARDINAL HEALTH - Hydrogel +AgEffective Antimicrobial silverEasy - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Hydrogel +AgEffective Antimicrobial silverEasy applicationPartial to full thickness wounds Hydrogel +AgEffective Antimicrobial silverEasy applicationPartial to full thickness wounds: -Pressure ulcers-Graft and donor sites-Leg ulcers-Post-operative surgical wounds-Lacerations and abrasions-Diabetic ulcers-First- and second-degree burns-Trauma woundsCardinal Health Hydrogel +Ag is an opaque, amorphous hydrogel containing an antimicrobial silver compound that is an effective barrier to bacterial penetration by inhibiting the growth of a broad spectrum of microorganisms that come into contact with the gel.Indications: Under the medical supervision of a healthcare professional for the management of dry to moderately exuding, partial and full thickness wounds, including pressure ulcers, graft and donor sites, leg ulcers, post-operative surgical wounds, lacerations, abrasions, diabetic ulcers, first- and second-degree burns, and trauma wounds (dermal lesions, trauma injuries or incisions). Contraindications: Do not use on patients with a known sensitivity to silver or propylene glycol.Caution: Frequent or prolonged use of this preparation may result in permanent discoloration of skin and mucous membranes. Directions for use: Cleanse wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Apply wound gel onto the wound bed, approximately 0.2 inches thick, ensuring wound gel does not cover healthy skin. Cover with an appropriate secondary dressing. Dressing may be left in place for up to 3 days. Please discard the tube and remaining gel 28 days after opening. External use only.Ingredients: water, propylene glycol, guar gum, mono potassium phosphate, silver carbonate, sodium chloride

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More Product Details

Catalog Number

HG15OZAG

Brand Name

CARDINAL HEALTH

Version/Model Number

HG15OZAG

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

FRO

Product Code Name

Dressing, wound, drug

Device Record Status

Public Device Record Key

b21c014b-4e86-485b-87bf-126d1803c62c

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

June 25, 2019

Additional Identifiers

Package DI Number

20888499001043

Quantity per Package

10

Contains DI Package

00888499001049

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