Identity
- Trade Name
- Aware Breast Self-Exam Pad FDA UDI
- Generic Name
- Breast self-examination pad FDA UDI
- Device Name
- The Aware™ Pad is intended to be used as an aid for performing breast self-examination. FDA UDI
- Model / Reference
- 1207 FDA UDI
- Description
- The Aware™ Pad is intended to be used as an aid for performing breast self-examination. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00083059012071 FDA UDI
- 510(k) Number
- K991469 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- Breast self-examination pad FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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
Yes
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: Breast self-examination pad
Aware Breast Self-Exam Pad by Biomerica, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Biomerica, Inc.
Sources (1)
- FDA UDI 8d79aa69-b7ee-46f2-93bd-c7e2fd0fa06d 35 fields · synced May 30, 2026