Identity
- Trade Name
- Silagen Silicone Gel Sheeting FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- 7360 Silagen Clear Silicone Abdomen Sheet, 2"x8" (5.1x20.3cm), 1 pc/package FDA UDI
- Model / Reference
- 7360 FDA UDI
- Description
- 7360 Silagen Clear Silicone Abdomen Sheet, 2"x8" (5.1x20.3cm), 1 pc/package FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816465020374 FDA UDI
- 510(k) Number
- K041704 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scar-management dressing, reusable
Silagen Silicone Gel Sheeting by Newmedical Technology, 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
Cleared under the same submission
K041704 also covers:
- NewGel+ Silicone Gel Sheeting — Newmedical Technology, Inc.
- NewGel+ Silicone Gel Sheeting — Newmedical Technology, Inc.
- NewGel+ Silicone Gel Sheeting — Newmedical Technology, Inc.
- NewGel+ Silicone Gel Sheeting — Newmedical Technology, Inc.
- NewGel+ Silicone Gel Sheeting — Newmedical Technology, Inc.
- NewGel+ Silicone Gel Sheeting — Newmedical Technology, Inc.
- NewGel+ Silicone Gel Sheeting — Newmedical Technology, Inc.
- NewGel+ Silicone Gel Sheeting — Newmedical Technology, Inc.
- NewGel+ Silicone Gel Sheeting — Newmedical Technology, Inc.
- NewGel+ Silicone Gel Sheeting — Newmedical Technology, Inc.
- NewGel+ Silicone Gel Sheeting — Newmedical Technology, Inc.
- NewGel+ Silicone Gel Sheeting — Newmedical Technology, Inc.
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
- Newmedical Technology, Inc.
Sources (1)
- FDA UDI df567926-47a3-4a4b-b7e7-aab158bae1db 36 fields · synced Jun 9, 2026