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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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PNE Lead
AXONICS MODULATION TECHNOLOGIES, INC.
1901
In Commercial Distribution

  • 10810005340127 ()
1901

  • Implantable electrical stimulation system intraoperative test lead
Remote Control
AXONICS MODULATION TECHNOLOGIES, INC.
2301
In Commercial Distribution

  • 10810005340103 ()
2301

  • Implantable incontinence-control electrical stimulation system programmer, battery-powered
Lead Implant Kit
AXONICS MODULATION TECHNOLOGIES, INC.
1801
In Commercial Distribution

  • 10810005340080 ()
1801

  • Neurosurgical procedure kit, non-medicated, single-use
Neurostimulator
AXONICS MODULATION TECHNOLOGIES, INC.
1101
In Commercial Distribution

  • 10810005340066 ()
1101

  • Sacral plexus implantable incontinence-control electrical stimulation system
Trial Stimulator
AXONICS MODULATION TECHNOLOGIES, INC.
1601
In Commercial Distribution

  • 10810005340059 ()
1601

  • Sacral plexus percutaneous incontinence-control electrical stimulation system pulse generator
Clinician Programmer
AXONICS MODULATION TECHNOLOGIES, INC.
2501
In Commercial Distribution

  • 10810005340035 ()
2501

  • Implantable incontinence-control electrical stimulation system programmer, line-powered
Charging System
AXONICS MODULATION TECHNOLOGIES, INC.
1401
In Commercial Distribution

  • 10810005340011 ()
1401

  • Implant battery charger
PROG 3037 INTRSTIM II PATIENT MRI UPDATE
MEDTRONIC, INC.
3037
In Commercial Distribution

  • 00643169170544 ()


  • Implantable incontinence-control electrical stimulation system programmer, battery-powered
LEAD 305901 PNE TST STIM FLXMED EMAN COO
MEDTRONIC, INC.
305901
Not in Commercial Distribution

  • 00643169781863 ()


  • Sacral plexus percutaneous incontinence-control electrical stimulation system electrode
LEAD 309101 PNE TEST STIM KIT EMAN US
MEDTRONIC, INC.
309101
Not in Commercial Distribution

  • 00643169721173 ()


  • Sacral plexus percutaneous incontinence-control electrical stimulation system electrode
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