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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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For use on: Skin Vegetations Fatty Grains Freckles Age Spots Warts Verruca Large Moles Large Freckles
HOME AIDE DIAGNOSTICS, INC.
FY-111
In Commercial Distribution

  • 10860003125585 ()
  • 00860003125588 ()


  • Scarifier
Peak flow meter for child use
HOME AIDE DIAGNOSTICS, INC.
EP70102
In Commercial Distribution

  • 10860003125578 ()
  • 00860003125571 ()
  • 20860003125575 ()


  • Peak flow meter, manual
No Description
Canary Medical USA LLC
43-5570-003-15
In Commercial Distribution

  • 00860003118382 ()


  • Patient health record information system
No Description
Canary Medical USA LLC
43-5570-005-14
In Commercial Distribution

  • 00860003118368 ()


  • Medical networking interface unit
No Description
Canary Medical USA LLC
43-5570-007-14
In Commercial Distribution

  • 00860003118344 ()


  • Electronic goniometer/kinesiology sensor
Dedicated Laptop PC, part of the OR Base Station System
Canary Medical USA LLC
43-5570-003-14
In Commercial Distribution

  • 00860003118337 ()


  • Patient health record information system
The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
Canary Medical USA LLC
43-5570-001-14
In Commercial Distribution

  • 00860003118320 ()


  • Medical networking interface unit
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution

  • 00860003118313 ()


  • Medical networking interface unit
No Description
CONCURE ONCOLOGY, INC.
AC-B3110
In Commercial Distribution

  • 00860003072776 ()


  • Patient radiation shielding pad/drape, reusable
No Description
CONCURE ONCOLOGY, INC.
80-FN1720
In Commercial Distribution

  • 00860003072769 ()


  • Manual brachytherapy system
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