SCARFADE Elite SFEP15

GUDID 00852869005197

Scar gel for scar management.

Hanson Medical, Inc.

Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable Scar-management dressing, reusable

• Primary Device ID: 00852869005197
• NIH Device Record Key: 4048a135-10cb-4936-80db-70b9676081f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCARFADE Elite
• Version Model Number: 021907-12
• Catalog Number: SFEP15
• Company DUNS: 049119329
• Company Name: Hanson Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com
• Phone: +1(800)771-2215
• Email: info@hansonmedical.com

Device Dimensions

• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram
• Weight: 15 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.
• Special Storage Condition, Specify: Between 0 and 0 *Excess application may stain clothing.
• Special Storage Condition, Specify: Between 0 and 0 *Keep this product out of the reach of children.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid using near eyes or mucus membranes.
• Special Storage Condition, Specify: Between 0 and 0 *Not for use on open wounds.
• Special Storage Condition, Specify: Between 0 and 0 *If redness or irritation occurs discontinue use and consult your physician.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852869005173 [Primary]
GS1	00852869005197 [Package]; Contains: 00852869005173; Package: Inner Pack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040307

FDA Product Code

• MDA: Elastomer, silicone, for scar management

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-27
• Device Publish Date: 2023-07-19

Devices Manufactured by Hanson Medical, Inc.

• 10852869005002 - SCARFADE: 2023-07-27 Scar gel for scar management.
• 10852869005019 - SCARFADE: 2023-07-27 Scar gel for scar management.
• 10852869005026 - SCARFADE: 2023-07-27 Scar gel for scar management.
• 10852869005033 - SCARFADE C: 2023-07-27 Scar gel for scar management.
• 00852869005197 - SCARFADE Elite: 2023-07-27Scar gel for scar management.
• 00852869005197 - SCARFADE Elite: 2023-07-27 Scar gel for scar management.