Identity
- Trade Name
- H&H FDA UDI
- Generic Name
- Scar-management dressing, single-use FDA UDI
- Device Name
- Effective treatment for scar 1. Maintain proper moist environment 2. Support and close the wound 3. Tissue well arrayed, reduce scar proliferation. FDA UDI
- Model / Reference
- SH2106 FDA UDI
- Description
- Effective treatment for scar 1. Maintain proper moist environment 2. Support and close the wound 3. Tissue well arrayed, reduce scar proliferation. FDA UDI
Identifiers
- Catalog Number
- SH2106 FDA UDI
- Primary DI / UDI-DI
- 04719884330252 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Scar-management dressing, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 21 Centimeter FDA UDIWidth — 6 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
Similar devices
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 4290bfe3-452f-4d32-8c07-b9669962ca28 35 fields · synced May 30, 2026