SCARFADE SFT15
GUDID 10852869005002
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 | 10852869005002 |
| NIH Device Record Key | 14019db0-ee1c-4395-9572-8929ceaa731d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SCARFADE |
| Version Model Number | 051106-4 |
| Catalog Number | SFT15 |
| 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 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| info@hansonmedical.com | |
| Phone | +1(800)771-2215 |
| 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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 *Avoid using near eyes or mucus membranes. |
| 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 *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 | 00852869005005 [Primary] |
| GS1 | 10852869005002 [Package] Contains: 00852869005005 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 |
On-Brand Devices [SCARFADE]
| 10852869005026 | Scar gel for scar management. |
| 10852869005019 | Scar gel for scar management. |
| 10852869005002 | Scar gel for scar management. |
Trademark Results [SCARFADE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCARFADE 76074381 2670931 Live/Registered |
Hanson Medical, Inc. 2000-06-21 |
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