Scar Fx

FDA UDI

Class I (US FDA UDI)

by Scar Heal

Identity

Trade Name: Scar Fx FDA UDI
Generic Name: Scar-management dressing, reusable FDA UDI
Device Name: Gelzone garment belt with silicone sheeting 6"x48" FDA UDI
Model / Reference: 10648 FDA UDI
Description: Gelzone garment belt with silicone sheeting 6"x48" FDA UDI

Identifiers

Catalog Number: 10648 FDA UDI
Primary DI / UDI-DI: 00642790106489 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

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Height — 6 Inch FDA UDI
Width — 48 Inch FDA UDI

Category: Scar-management dressing, reusable

Scar Fx by Scar Heal — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Scar-management dressing, reusable.

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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

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: Scar Heal

Sources (1)

FDA UDI 61c5b3aa-f9eb-4ea6-b845-1298dfaf7edb 37 fields · synced May 30, 2026