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)
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
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
611efc67-961a-445d-b59e-946cf20112e8
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
June 25, 2019
Package DI Number
00888499000998
Quantity per Package
5
Contains DI Package
10885380065064
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 |