The Aware™ Pad is intended to be used as an aid for performing breast self-examination.

Product Overview

The Aware™ Pad is intended to be used as an aid for performing breast self
Aware Breast Self-Exam Pad - 1207

Device Description

A device intended to be used to perform a tactile self-breast examination for abnormalities, typically unfamiliar changes/lumps in the soft tissue of the breast. It is typically pouch-shaped and made of thin, flexible, plastic (e.g., polyurethane) that contains a small quantity of fluid silicone and/or air, allowing it to conform to the user's breast and reduce skin friction between the hand and the surface of the breast. The device will allow the user to sense subtle tissue density variations. This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: IYO

Device Name: System, Imaging, Pulsed Echo, Ultrasonic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1560

Third Party Flag: Y

Medical Specialty: RA

Device Identifiers

Device Id: 00083059012071

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Educational Resources