FDA UDI
In Commercial Distribution
🇺🇸 United States
SCARFADE C
DI: 00852869005036
·
Model: 031606-5
·
Hanson Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- SCARFADE C
- Primary DI
- 00852869005036
- Version / Model
- 031606-5
- Catalog Number
- SFCT15
- Company Name
- Hanson Medical, Inc.
- Labeler DUNS
- 049119329
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-19
- Public Version
- 2
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 56246b0d-7283-4c2b-b9ae-5b83fee328be
Device Description
Scar gel for scar management.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MDA | Elastomer, silicone, for scar management | General, Plastic Surgery | 878.4025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44898 | Scar-management dressing, reusable | 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 | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10852869005033 | GS1 | Inner Pack | 10 | In Commercial Distribution | |
| Primary | 00852869005036 | GS1 |
Customer Contacts
- Phone
- +1(800)771-2215
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040307 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 15 | Gram |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Not for use on open wounds.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep this product out of the reach of children.
- Type
- Special Storage Condition, Specify
- Special Conditions
- If redness or irritation occurs discontinue use and consult your physician.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid using near eyes or mucus membranes.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Excess application may stain clothing.