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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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Small L300 System Kit, Left US
BIONESS INC.
LG3-5V00
Not in Commercial Distribution

  • 07290110483081 ()
501-00169-01

  • Gait-enhancement electrical stimulation system, external
Regular L300 Clinician's Kit US
BIONESS INC.
LG3-4000
Not in Commercial Distribution

  • 07290110483074 ()
501-00161-01

  • Gait-enhancement electrical stimulation system, external
Regular L300 System Kit, Right US
BIONESS INC.
LG3-5000
Not in Commercial Distribution

  • 07290110483067 ()
501-00159-01

  • Gait-enhancement electrical stimulation system, external
Regular L300 System Kit, Left US
BIONESS INC.
LG3-5100
Not in Commercial Distribution

  • 07290110483050 ()
501-00158-01

  • Gait-enhancement electrical stimulation system, external
L300 Plus US Clinician's Upgrade Kit
BIONESS INC.
L3P-4100
Not in Commercial Distribution

  • 07290110483043 ()
501-00046-01

  • Gait-enhancement electrical stimulation system, external
L300 Plus US Upgrade System Kit, Right (regular)
BIONESS INC.
L3P-5100
Not in Commercial Distribution

  • 07290110483036 ()
501-00127-01

  • Gait-enhancement electrical stimulation system, external
L300 Plus US Upgrade System Kit, Left (regular)
BIONESS INC.
L3P-5101
Not in Commercial Distribution

  • 07290110483029 ()
501-00126-01

  • Gait-enhancement electrical stimulation system, external
L300 Plus US System Kit, Right (regular)
BIONESS INC.
L3P-5000
Not in Commercial Distribution

  • 07290110483012 ()
501-00123-01

  • Gait-enhancement electrical stimulation system, external
L300 Plus US System Kit, Left (regular)
BIONESS INC.
L3P-5001
Not in Commercial Distribution

  • 07290110483005 ()
501-00122-01

  • Gait-enhancement electrical stimulation system, external
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M014911
In Commercial Distribution

  • 00817020020310 ()


  • Somatosensory electrical stimulation system
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