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
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
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
FRO
Product Code Name
Dressing, wound, drug
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
Package DI Number
20888499001043
Quantity per Package
10
Contains DI Package
00888499001049
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
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 |