Duns Number:961027315
Device Description: Reinforced Gelling Fiber2 x 2 in. DressingPartial to full thickness wounds: -Pressure ulce Reinforced Gelling Fiber2 x 2 in. DressingPartial to full thickness wounds: -Pressure ulcers-Graft and donor sites-Venous, arterial and diabetic ulcers-Post-operative surgical wounds-Lacerations and abrasions-Cavity wounds-Trauma wounds-Superficial and partial thickness woundsHighly absorbent gelling fibersCohesive fiber constructionDirections 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-Graft and donor sites-Venous, arterial and diabetic ulcers-Post-operative surgical wounds-Lacerations and abrasions-Cavity wounds-Trauma wounds-Superficial and partial thickness woundsCan also be used to control minor bleeding in superficial wounds.
Catalog Number
RGFB22
Brand Name
CARDINAL HEALTH
Version/Model Number
RGFB22
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAC
Product Code Name
Dressing, wound, hydrophilic
Public Device Record Key
f026069b-e5c8-4881-a0a2-63056a7c54d3
Public Version Date
July 22, 2021
Public Version Number
3
DI Record Publish Date
June 25, 2019
Package DI Number
10888499000964
Quantity per Package
10
Contains DI Package
00888499000967
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
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 |