Primary Device ID | 00083059012071 |
NIH Device Record Key | 8d79aa69-b7ee-46f2-93bd-c7e2fd0fa06d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Aware Breast Self-Exam Pad |
Version Model Number | 1207 |
Company DUNS | 067647321 |
Company Name | BIOMERICA, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +1 949 645 2111 |
info@biomerica.com | |
Phone | +1 949 645 2111 |
info@biomerica.com | |
Phone | +1 949 645 2111 |
info@biomerica.com | |
Phone | +1 949 645 2111 |
info@biomerica.com | |
Phone | +1 949 645 2111 |
info@biomerica.com | |
Phone | +1 949 645 2111 |
info@biomerica.com | |
Phone | +1 949 645 2111 |
info@biomerica.com | |
Phone | +1 949 645 2111 |
info@biomerica.com | |
Phone | +1 949 645 2111 |
info@biomerica.com | |
Phone | +1 949 645 2111 |
info@biomerica.com | |
Phone | +1 949 645 2111 |
info@biomerica.com | |
Phone | +1 949 645 2111 |
info@biomerica.com | |
Phone | +1 949 645 2111 |
info@biomerica.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00083059012071 [Primary] |
IYO | System, Imaging, Pulsed Echo, Ultrasonic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-07-09 |
Device Publish Date | 2020-07-01 |
00083059012071 | The Aware™ Pad is intended to be used as an aid for performing breast self-examination. |
00083059012033 | The Aware™ Pad is intended to be used as an aid for performing breast self-examination. |
08305900012033 | The Aware™ Pad is intended to be used as an aid for performing breast self-examination. |