Silicone Gel Sheet. Treatment for red and raised, old and new scars

Silicone Gel Sheet. Treatment for red and raised, old and new scars
CicaCare 12cm x 6cm Ctn of 1 Global - 66250704

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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 05000223441784

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05000223441586

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 05000223441586

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: 05000223441791

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05000223441784

Package Quantity: 20

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 05000223441807

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05000223441784

Package Quantity: 40

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case 66250705