Identity
- Trade Name
- Vivera Pharmaceuticals, Inc FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning. FDA UDI
- Model / Reference
- Silinoin FDA UDI
- Description
- A non-sterile covering made of a silicone-based material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device after appropriate cleaning. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00372380000384 FDA UDI
- 510(k) Number
- K003948 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
Yes
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
Vivera Pharmaceuticals, Inc by Vivera Pharmaceuticals, 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
K003948 also covers:
- DERMASOF — BIODERMIS LLC
- Vivera Pharmaceuticals — VIVERA PHARMACEUTICALS, INC.
- szosil medical grade silicone gel sheeting for scar — VIVERA PHARMACEUTICALS, INC.
- szosil medical grade silicone sheeting gel for scars — VIVERA PHARMACEUTICALS, INC.
- szosil silicone stick — VIVERA PHARMACEUTICALS, INC.
- szosil skin repair serum — VIVERA PHARMACEUTICALS, 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
- Vivera Pharmaceuticals, Inc.
Sources (1)
- FDA UDI c7ee4b2e-a99b-4720-9905-bfe3fd82e4da 35 fields · synced May 30, 2026