SCARFADE Elite SFEP15

GUDID 00852869005197

Scar gel for scar management.

Hanson Medical, Inc.

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.

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• 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.