FDA.reportPublic FDA data

Aware Breast Self-Exam Pad

Primary DI
08305900012033
Brand
Aware Breast Self-Exam Pad
Company
BIOMERICA, INC.
Model
1203
Device description
The Aware™ Pad is intended to be used as an aid for performing breast self-examination.
Published
2016-12-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991469000AWARE PADAac Consulting Group, Inc.1999-07-20IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08305900012033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08305900012033083059000120338305900012033

GMDN Terms#

Term, Definition table
TermDefinition
Breast self-examination padA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 949 645 2111info@biomerica.com

Regulatory Flags#

DUNS number
067647321
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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