Identity
- Trade Name
- Oleeva Fabric Breast Kit SMALL FDA UDI
- Generic Name
- Scar-management dressing, reusable FDA UDI
- Device Name
- Silicone Gel Sheeting bonded with Fabric FDA UDI
- Model / Reference
- 37BKS FDA UDI
- Description
- Silicone Gel Sheeting bonded with Fabric FDA UDI
Identifiers
- Catalog Number
- 37BKS FDA UDI
- Primary DI / UDI-DI
- 00810050460545 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
Category: Scar-management dressing, reusable
Oleeva Fabric Breast Kit SMALL 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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- THERAFOAM — BIODERMIS LLC · Class I
- 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 fc18c7a9-5907-45d5-a4b4-d7bc2447517f 35 fields · synced May 30, 2026