Duns Number:961027315
Device Description: Cardinal Health Silicone Bordered Foam9.2 x 9.2in Sacral DressingPartial to full thickness Cardinal Health Silicone Bordered Foam9.2 x 9.2in Sacral DressingPartial to full thickness wounds: -Pressure ulcers-Traumatic wounds (eg. skin tears, road rash and minor injuries)-Diabetic, venous, and arterial ulcers-Graft and donor sites-Post-operative surgical wounds-Lacerations and abrasionsDirections for use: 1. Clean wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Dry surrounding skin thoroughly. Skin barrier products are not necessary.2. Remove dressing from packaging. For dressings smaller than 5x5 inches, there should be a 3/4-inch overlap onto the dry skin surrounding the wound. For dressings larger than 5x5 inches, there should be a 2-inch overlap. Do not stretch or cut product. 3. Apply adherent side of dressing over wound considering the overlap recommendations to protect the surrounding skin. Secondary dressing or additional fixation is not necessary.3. All dressings should be monitored frequently. Remove dressing when clinically indicated, such as leakage or increased pain, or after a maximum of 7 days.Not made with natural rubber latexIndications: May be used for the management of moderate to heavy exuding, partial to full thickness wounds, including:-Pressure ulcers-Traumatic wounds (eg. skin tears, road rash and minor injuries)-Diabetic, venous, and arterial ulcers-Graft and donor sites-Post-operative surgical wounds-Lacerations and abrasions
Catalog Number
BFMLGSCRL
Brand Name
CARDINAL HEALTH
Version/Model Number
BFMLGSCRL
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"
-
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
NAD
Product Code Name
Dressing, wound, occlusive
Public Device Record Key
b43ac22d-bfdf-415e-b15f-cece48fd1a03
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
May 30, 2019
Package DI Number
00888499001254
Quantity per Package
5
Contains DI Package
10885380065439
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 |