Identity
- Trade Name
- Oleeva Foam 5x5 FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- Silicone Gel Sheeting bonded with Foam FDA UDI
- Model / Reference
- 3225 FDA UDI
- Description
- Silicone Gel Sheeting bonded with Foam FDA UDI
Identifiers
- Catalog Number
- 3225 FDA UDI
- Primary DI / UDI-DI
- 00810050460170 FDA UDI
- 510(k) Number
- K002109 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 5 Inch FDA UDILength — 5 Inch FDA UDIWidth — 13 Centimeter FDA UDILength — 13 Centimeter FDA UDI
Category: Scar-management dressing, reusable
Oleeva Foam 5x5 by Bio Med Sciences, 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
- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc. · Class I
- THERAFOAM — BIODERMIS LLC · Class I
- Silagen Silicone Gel Sheeting — Newmedical Technology, Inc. · Class I
Cleared under the same submission
K002109 also covers:
- Oleeva Foam 1.5x5 — BIO MED SCIENCES, INC.
- Oleeva Foam 11x12 — BIO MED SCIENCES, INC.
- Oleeva Foam 5.2x2.2 — BIO MED SCIENCES, INC.
- Oleeva Foam Abdominoplasty Shape — BIO MED SCIENCES, INC.
- Oleeva Foam Breast Anchor Shape — BIO MED SCIENCES, INC.
- Oleeva Foam Breast Areola Shape — BIO MED SCIENCES, INC.
- Oleeva Foam Breast Kit — BIO MED SCIENCES, INC.
- Oleeva Foam C-Section — BIO MED SCIENCES, INC.
- Oleeva Foam Vertical Mastopexy Shape — BIO MED SCIENCES, 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
- Bio Med Sciences, Inc.
Sources (1)
- FDA UDI f61b3a04-2314-4fc2-a29e-44ea4f5faadf 37 fields · synced May 30, 2026