SCARFADE SFT15
GUDID 10852869005002
Scar gel for scar management.
Hanson Medical, Inc.
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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