Silicone Gel Sheet. Treatment for red and raised, old and new scars
CICA-CARE 15CM X 12CM - 66250706, 66250707
Device Description
A covering made of, or coated with, a synthetic polymer material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MDA
Device Name: Elastomer, Silicone, For Scar Management
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 878.4025
Third Party Flag: N
Medical Specialty: SU
Device Identifiers
Device Id: 05000223441814
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05000223441579
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton 66250706
Device Id: 05000223441579
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 05000223441821
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05000223441814
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case 66250706
Device Id: 05000223441654
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05000223441579
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton 66250707
Device Id: 05000223498351
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 05000223441654
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case 66250707
