CARDINAL HEALTH - Reinforced Gelling Fiber +Ag.75 x 18 in. - Cardinal Health 200, LLC

Duns Number:961027315

Device Description: Reinforced Gelling Fiber +Ag.75 x 18 in. RopePartial to full thickness wounds: -Pressure u Reinforced Gelling Fiber +Ag.75 x 18 in. RopePartial to full thickness wounds: -Pressure ulcers-Leg ulcers-Diabetic ulcers-Post-operative surgical wounds-First- and second-degree burns-Graft and donor sites-Trauma wounds (dermal lesions, trauma injuries or incisions)Highly absorbent gelling fibersCohesive fiber constructionEffective antimicrobial silverDirections for use: 1. Clean wound area with an appropriate wound cleanser such as Cardinal Health Wound Cleanser or normal saline solution. Dry surrounding skin thoroughly.2. Remove dressing from packaging and if necessary cut dressing to size using sterile scissors.3. Apply dressing over the wound bed leaving a 1/2-inch overlap. If wound is deep, loosely fill wound ensuring that the dressing does not overlap wound margins. Product will expand to fill the empty wound space once in contact with the exudate. Dressing can be pre-moistened with room temperature sterile water or saline solution before application.4. Cover wound and this primary dressing with a non-occlusive secondary dressing to promote a moist wound healing environment.5. All dressings should be monitored frequently. Remove dressing when clinically indicated, such as leakage, excessive bleeding, increased pain, or after a maximum of 7 days. IndicationsMay be used for the management of moderate to heavy exuding, partial to full thickness wounds including: -Pressure ulcers-Leg ulcers-Diabetic ulcers-Post-operative surgical wounds-First- and second-degree burns-Graft and donor sites-Trauma wounds (dermal lesions, trauma injuries or incisions)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

RGFBROPEAG

Brand Name

CARDINAL HEALTH

Version/Model Number

RGFBROPEAG

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

611efc67-961a-445d-b59e-946cf20112e8

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

June 25, 2019

Additional Identifiers

Package DI Number

00888499000998

Quantity per Package

5

Contains DI Package

10885380065064

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