Aware Breast Self-Exam Pad

GUDID 08305900012033

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

BIOMERICA, INC.

Breast self-examination pad
Primary Device ID08305900012033
NIH Device Record Key1ca6430e-d524-4f21-b85a-0c085b7c5701
Commercial Distribution Discontinuation2020-07-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAware Breast Self-Exam Pad
Version Model Number1203
Company DUNS067647321
Company NameBIOMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com
Phone+1 949 645 2111
Emailinfo@biomerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108305900012033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-09-02
Device Publish Date2016-12-07

On-Brand Devices [Aware Breast Self-Exam Pad]

00083059012071The Aware™ Pad is intended to be used as an aid for performing breast self-examination.
00083059012033The Aware™ Pad is intended to be used as an aid for performing breast self-examination.
08305900012033The Aware™ Pad is intended to be used as an aid for performing breast self-examination.

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