H&H

FDA UDI

Class I (US FDA UDI)

by Tronjen Medical Technology Inc.

Identity

Trade Name: H&H FDA UDI
Generic Name: Scar-management dressing, single-use FDA UDI
Device Name: Hydration healing for wounds 1. absorbing exudate (reduce the number of dressing changes, to avoid interference with woundhealing) 2. Non-adherent and Non-linting (Easy to remove, won’t cause wound trama) 3. Perfect conformity (Conform to wound’sfigure perfectly, patients feel comfortable in their daily movements) FDA UDI
Model / Reference: HW0505 FDA UDI
Description: Hydration healing for wounds 1. absorbing exudate (reduce the number of dressing changes, to avoid interference with woundhealing) 2. Non-adherent and Non-linting (Easy to remove, won’t cause wound trama) 3. Perfect conformity (Conform to wound’sfigure perfectly, patients feel comfortable in their daily movements) FDA UDI

Identifiers

Catalog Number: HW0505 FDA UDI
Primary DI / UDI-DI: 04719884330122 FDA UDI
FDA Product Code: NAE FDA UDI
GMDN Term: Scar-management dressing, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4022 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 5 Centimeter FDA UDI
Width — 5 Centimeter FDA UDI

Category: Scar-management dressing, single-use

H&H by Tronjen Medical Technology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Scar-management dressing, single-use.

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NEW BEGINNINGS® GELSHAPES® — Pmt Corp. · Class I
ScarMD — AIM MEDICAL INC · Class I
ScarAway Silicone Scar Gel — ALLIANCE PHARMA INC. · Class I
Lorski — Shandong Zhushi Pharmaceutical Group Co., Ltd. First Office · Class I
NEW BEGINNINGS® GELSHAPES® — Pmt Corp. · 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: Tronjen Medical Technology Inc.

Sources (1)

FDA UDI 224f6128-0c40-4f7f-a9d8-747e40684d81 35 fields · synced Jun 7, 2026