Identity
- Trade Name
- Optiheal Silicone Wound Recovery Strips FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- Silicone Wound Recovery Strips 1.6x6in / 4.1x15.2cm FDA UDI
- Model / Reference
- AW005A FDA UDI
- Description
- Silicone Wound Recovery Strips 1.6x6in / 4.1x15.2cm FDA UDI
Identifiers
- Catalog Number
- AW005 FDA UDI
- Primary DI / UDI-DI
- 00819333029059 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Scar-management dressing, reusable
Optiheal Silicone Wound Recovery Strips by Neo G USA 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
- Blister plaster — Shenzhen Huashengyuan Technology Co., Ltd · Class I
- Transeal Triple Release — DEROYAL INDUSTRIES, INC. · Class I
- URGO Ongles abimés, par mycoses et traumatismes légers — Laboratoires URGO HEALTHCARE · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neo G USA Inc
Sources (1)
- FDA UDI 6e2ac819-932e-4a83-87dd-b9d6de0e565a 34 fields · synced May 30, 2026