Oleeva Fabric 8x12

FDA UDI

Class I (US FDA UDI)

by Bio Med Sciences, Inc.

Identity

Trade Name: Oleeva Fabric 8x12 FDA UDI
Generic Name: Scar-management dressing, reusable FDA UDI
Device Name: Silicone Gel Sheeting bonded with Fabric FDA UDI
Model / Reference: 3796 FDA UDI
Description: Silicone Gel Sheeting bonded with Fabric FDA UDI

Identifiers

Catalog Number: 3796 FDA UDI
Primary DI / UDI-DI: 00810050460446 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 12 Inch FDA UDI
Width — 8 Inch FDA UDI
Length — 30 Centimeter FDA UDI
Width — 20 Centimeter FDA UDI

Category: Scar-management dressing, reusable

Oleeva Fabric 8x12 by Bio Med Sciences, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Scar-management dressing, reusable.

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Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc. · Class I
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Silagen Silicone Gel Sheeting — Newmedical Technology, Inc. · 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: Bio Med Sciences, Inc.

Sources (1)

FDA UDI bb85903e-9229-4942-94bf-9ab56aecae08 36 fields · synced Jun 8, 2026