SCARFADE Elite

FDA UDI

Class I (US FDA UDI)

by Hanson Medical, Inc.

Identity

Trade Name: SCARFADE Elite FDA UDI
Generic Name: Scar-management dressing, reusable FDA UDI
Device Name: Scar gel for scar management. FDA UDI
Model / Reference: 021907-12 FDA UDI
Description: Scar gel for scar management. FDA UDI

Identifiers

Catalog Number: SFEP15 FDA UDI
Primary DI / UDI-DI: 00852869005173 FDA UDI
510(k) Number: K040307 FDA UDI
FDA Product Code: MDA FDA UDI
GMDN Term: Scar-management dressing, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4025 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Weight — 15 Gram FDA UDI

Category: Scar-management dressing, reusable

SCARFADE Elite by Hanson Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Scar-management dressing, reusable.

MEDLOT — Henan Maidingkang Medical Technology Co., Ltd. · Class I
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Wound Plaster — Jinhua Jingdi Medical Supplies Co.,Ltd. · Class I
Oleeva Fabric 2x8 — BIO MED SCIENCES, INC. · Class I
Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc. · Class I
THERAFOAM — BIODERMIS LLC · Class I

Cleared under the same submission

K040307 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Hanson Medical, Inc.

Sources (1)

FDA UDI 4048a135-10cb-4936-80db-70b9676081f2 38 fields · synced Jun 9, 2026