UDI device identifier

Aware Breast Self-Exam Pad 1203

UDI device identifier 00083059012033 · BIOMERICA, INC.

Key facts

Primary DI 00083059012033
Brand name Aware Breast Self-Exam Pad
Version or model 1203
Company BIOMERICA, INC.
DUNS number 067647321
Product code IYO
GMDN term Breast self-examination pad
Premarket submission K991469
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Jul 1, 2020
Version date Jul 9, 2020
Description The Aware™ Pad is intended to be used as an aid for performing breast self-examination.

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • Yes EUDAMED counterpart found
  • 1,000+ GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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