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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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L300 Go System, Right Small Lower
Bioness Medical, Inc.
LG4-5U00
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external
L300 Go System, Right Lower
Bioness Medical, Inc.
LG4-5000
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external
L360 Thigh System Kit, Left
Bioness Medical, Inc.
L4T-6001
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external
L100 Go System, Left
Bioness Medical, Inc.
LG1-5X00
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external
L300 Go System, Left Thigh Plus
Bioness Medical, Inc.
L4P-5001
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external
L300 Go System, Left Lower
Bioness Medical, Inc.
LG4-5100
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external
L360 Thigh System Kit, Right
Bioness Medical, Inc.
L4T-6000
In Commercial Distribution



  • Gait-enhancement electrical stimulation system, external
Case for storage/transport of ROSC-U, with wheels
RESUSCITATION INTERNATIONAL, LLC
A03-WB-000
In Commercial Distribution

  • 00860000876285 ()
A03-WB-000

  • Cardiac resuscitator, battery-powered
Case used for carrying and/or storage of ROSC-U
RESUSCITATION INTERNATIONAL, LLC
A03-PB-000
In Commercial Distribution

  • 00860000876278 ()
A03-PB-000

  • Cardiac resuscitator, battery-powered
Head Stabilizer used to limit head movement during resuscitation
RESUSCITATION INTERNATIONAL, LLC
A02-55-135
In Commercial Distribution

  • 00860000876261 ()
A02-55-135

  • Cardiac resuscitator, battery-powered
Battery Charger
RESUSCITATION INTERNATIONAL, LLC
A03-10-000
In Commercial Distribution

  • 00860000876254 ()
A03-10-000

  • Cardiac resuscitator, battery-powered
Disposables Pack, 5 ea of XL Torso Restraints and Head Stabilizer Covers
RESUSCITATION INTERNATIONAL, LLC
A02-60-134
In Commercial Distribution

  • 00860000876247 ()
A02-60-134

  • Cardiac resuscitator, battery-powered
Disposables Pack, 10 ea of Torso Restraints and Head Stabilizer Covers
RESUSCITATION INTERNATIONAL, LLC
A02-58-134
In Commercial Distribution

  • 00860000876230 ()
A02-58-134

  • Cardiac resuscitator, battery-powered
Compressor Unit
RESUSCITATION INTERNATIONAL, LLC
A03-1C-000
In Commercial Distribution

  • 00860000876223 ()
A03-1C-000

  • Cardiac resuscitator, battery-powered
Battery Control Unit
RESUSCITATION INTERNATIONAL, LLC
A03-1B-000
In Commercial Distribution

  • 00860000876216 ()
A03-1B-000

  • Cardiac resuscitator, battery-powered
Mechanical CPR system, including Battery Control Unit, Compressor, Torso Restraints (10 pk), Torso Restraints XL (5 pk), Battery Charger
RESUSCITATION INTERNATIONAL, LLC
A03-01-000
In Commercial Distribution

  • 00860000876209 ()
A03-01-000

  • Cardiac resuscitator, battery-powered
No Description
S2 Equipment LLC
NCP-5
In Commercial Distribution

  • 00865089000316 ()


  • External counterpulsation system, mobile
No Description
Labtician Ophthalmics, Inc
SGP20
In Commercial Distribution

  • 00871321002956 ()


  • Eyelid weight, implantable
No Description
Labtician Ophthalmics, Inc
NST300
In Commercial Distribution

  • 00871321002895 ()


  • Eyelid weight, implantable
No Description
Labtician Ophthalmics, Inc
NST200
In Commercial Distribution

  • 00871321002888 ()


  • Eyelid weight, implantable
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