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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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The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applicable reports for the oncoReveal CDx
Pillar Biosciences, Inc.
SFW-2012 2.0
In Commercial Distribution

  • 00860001218275 ()
SFW-2012

  • Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
No Description
WAHTS HEARING LLC
0.X.X
In Commercial Distribution

  • 00860005068319 ()


  • Tone audiometer
Breathing therapy Biofeedback System
ACCELERATED CARE PLUS CORP
FlowSoftware
In Commercial Distribution

  • 00858703006313 ()


  • Bioelectrical signal analysis software
No Description
Norland at Swissray
4
In Commercial Distribution

  • 00866955000478 ()


  • Basic diagnostic x-ray system operation software
Software used for the interaction and programming of the Novi Device.
SCOTTCARE CORPORATION, THE
Novi Software
In Commercial Distribution

  • 00856298006237 ()
101633

  • Electrocardiographic long-term ambulatory recording analyser application software
Software used for interaction and programming of the TeleSenseRCM and TeleSense-E devices.
SCOTTCARE CORPORATION, THE
TeleSense Software
In Commercial Distribution

  • 00856298006213 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
Supplemental Software provided on a thumb drive. Enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014300-000
Not in Commercial Distribution

  • 00856264005776 ()
014300

  • Retinal prosthesis system tester/clinical evaluator
SeeMore Software 2.0.03 Urology
INTERSON CORP
2.0.03 URO
In Commercial Distribution

  • 00850921007066 ()
98-3517-02

  • Extracorporeal ultrasound imaging transducer, hand-held
SeeMore Software 4.4.x
INTERSON CORP
4.4.x
In Commercial Distribution

  • 00850921007172 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
SeeMore Software 4.2.1 Urology
INTERSON CORP
4.2.1 URO
In Commercial Distribution

  • 00850921007165 ()
98-3528-03

  • Extracorporeal ultrasound imaging transducer, hand-held
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