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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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AcQMap System
ACUTUS MEDICAL, INC.
900000
Not in Commercial Distribution

  • 00857042007999 ()
900000

  • Cardiac mapping system
AcQMap System Console 2.0
ACUTUS MEDICAL, INC.
900100
Not in Commercial Distribution

  • 00857042007920 ()
900100

  • Cardiac mapping system
AcQMap Patient Electrode Kit
ACUTUS MEDICAL, INC.
800605
Not in Commercial Distribution

  • 00857042007562 ()
800605

  • Cardiac mapping system reference patch
AcQMap Auxiliary Interface Box, Console 2.0
ACUTUS MEDICAL, INC.
800604
Not in Commercial Distribution

  • 00857042007425 ()
800604

  • Patient monitoring system module, interfacing
POAG Cable MC-POAG-EC6/2
ACUTUS MEDICAL, INC.
800405
Not in Commercial Distribution

  • 00857042007364 ()
800405

  • Electrical-only medical device connection cable, reusable
Power Cord, Console 2.0
ACUTUS MEDICAL, INC.
800601
Not in Commercial Distribution

  • 00857042007333 ()
800601

  • Electrical-only medical device connection cable, reusable
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted GE Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082625 ()


  • MRI image interpretive software
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted On-Premise
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082618 ()
580SW.01

  • MRI image interpretive software
ProstatID™ MRI Diagnostic Aid for Prostate Cancer - Hosted Terrarecon Platform
Bot Image, Inc.
ProstatID™
In Commercial Distribution

  • 00860009082601 ()


  • MRI image interpretive software
No Description
Icad, Inc.
2.1
In Commercial Distribution

  • 00858012005960 ()


  • Basic diagnostic x-ray system application software
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