Duns Number:961027315
Device Description: Silicone Contact Layer4 x 7in. DressingPartial to full thickness wounds:-Skin tears-Surgic Silicone Contact Layer4 x 7in. DressingPartial to full thickness wounds:-Skin tears-Surgical and trauma wounds-Blisters, cuts, and lacerations-Pressure ulcers-Venous ulcers-First- and second-degree burns-Dry to heavily draining abrasionsConformable, translucent, open mesh structureFacilitates fluid transferGentle silicone adhesiveDirections for use: 1. Clean wound area with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Dry surrounding skin thoroughly.2. Remove dressing from packaging and if necessary cut dressing to size using sterile scissors. The dressing can cover peri-wound skin. If more than one pieces is required, overlap the dressings making sure the pores are not blocked.3. Remove one side of the release liner and affix dressing over wound. Remove second release liner and smooth in place onto the surrounding skin for optimal seal. Tip: moisten fingertips of gloves with sterile water or normal saline solution for easy handling.4. Cover with a moisture retentive secondary dressing such as Cardinal Health Composite Dressing to protect and promote a moist wound healing environment. Can also be used under compression bandages.5. All dressings should be monitored frequently. Dressing can be worn up to 7 days depending on condition of the wound and surrounding skin, or as indicated as accepted by clinical practice. Exudate should pass freely through the dressing and pores should not be blocked.Indications: May be used to allow passage of exudate and provide fixation and protection of the wound bed during dressing changes for a wide variety of partial to full thickness wounds, including: -Skin tears-Surgical and trauma wounds-Blisters, cuts, and lacerations-Pressure ulcers-Venous ulcers-First- and second-degree burns-Dry to heavily draining abrasions
Catalog Number
SCL47
Brand Name
CARDINAL HEALTH
Version/Model Number
SCL47
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
d71481f2-4653-4821-a5fd-661bba27db72
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
May 30, 2019
Package DI Number
10888499001312
Quantity per Package
5
Contains DI Package
00888499001315
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 |