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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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ZeroG-Passive System - 00850018836067

The ZeroG-Passive System is intended to assist subjects with neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG-Passive should never be connected to inanimate objects. ZeroG-Passive should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use.
ARETECH, LLC
ZGP-110
In Commercial Distribution

  • 00850018836067 ()


  • Gait rehabilitation frame, manual

Ovation 700 - 00850018836043

The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer. The Ovation 700 model allows for a patient weight capacity of up to 700 pounds with a dynamic body-weight support range of 25 to 300 pounds.
ARETECH, LLC
OV-700
In Commercial Distribution

  • 00850018836043 ()


  • Gait rehabilitation frame, electric

Ovation 400 - 00850018836029

The Ovation system is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. Ovation should never be used to lift subjects off the ground and should never be connected to inanimate objects. Ovation should only be operated by clinicians and trained healthcare professionals who have read and understand the instructions for use and have passed the Ovation training competency exam conducted by an Aretech trainer or a certified staff trainer. The Ovation 400 model allows for a patient weight capacity of up to 400 pounds with a dynamic body-weight support range of 10 to 200 pounds.
ARETECH, LLC
OV-400
In Commercial Distribution

  • 00850018836029 ()


  • Gait rehabilitation frame, electric

ZeroG Gait & Balance System - 00850018836012

The ZeroG Gait & Balance System is intended to assist subjects who have experienced neurological and orthopedic injuries as they practice therapeutic activities related to walking, balance activities and postural control tasks. ZeroG can also be used to train subjects ambulating on a treadmill. ZeroG should never be used to lift and transport subjects, and should never be connected to inanimate objects. ZeroG should only be operated by therapists and trained healthcare professionals who have read and understand the instructions for use and have passed the ZeroG training competency exam conducted by an Aretech trainer or a certified staff trainer.
ARETECH, LLC
ZGGB-V3
In Commercial Distribution

  • 00850018836012 ()


  • Gait rehabilitation frame, electric

Macro Depth Electrode - 00841823109705

No Description
Ad-Tech Medical Instrument Corporation
9
In Commercial Distribution

  • 00841823109705 ()
BF08R-SP61X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109682

No Description
Ad-Tech Medical Instrument Corporation
7
In Commercial Distribution

  • 00841823109682 ()
BF09R-SP21X-0CC

  • Depth electrode

Macro Depth Electrode - 00841823109668

No Description
Ad-Tech Medical Instrument Corporation
5
In Commercial Distribution

  • 00841823109668 ()
BF10R-SP05X-0BH

  • Depth electrode

Macro Depth Electrode - 00841823109644

No Description
Ad-Tech Medical Instrument Corporation
3
In Commercial Distribution

  • 00841823109644 ()
BF10R-SP61X-0C3

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109477

No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP05X-000
In Commercial Distribution

  • 00841823109477 ()
SD14R-SP05X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109453

No Description
Ad-Tech Medical Instrument Corporation
SD13R-SP45X-0T2
In Commercial Distribution

  • 00841823109453 ()
SD13R-SP45X-0T2

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109439

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP10X-000
In Commercial Distribution

  • 00841823109439 ()
SD12R-SP10X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109415

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP06X-000
In Commercial Distribution

  • 00841823109415 ()
SD12R-SP06X-000

  • Depth electrode

Macro Depth Electrode - 00841823109729

No Description
Ad-Tech Medical Instrument Corporation
11
In Commercial Distribution

  • 00841823109729 ()
BF08R-SP05X-0BH

  • Depth electrode

Macro Depth Electrode - 00841823109712

No Description
Ad-Tech Medical Instrument Corporation
10
In Commercial Distribution

  • 00841823109712 ()
BF08R-SP21X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109699

No Description
Ad-Tech Medical Instrument Corporation
8
In Commercial Distribution

  • 00841823109699 ()
BF09R-SP05X-0BE

  • Depth electrode

Macro Depth Electrode - 00841823109675

No Description
Ad-Tech Medical Instrument Corporation
6
In Commercial Distribution

  • 00841823109675 ()
BF09R-SP61X-0CC

  • Depth electrode

Macro Depth Electrode - 00841823109651

No Description
Ad-Tech Medical Instrument Corporation
4
In Commercial Distribution

  • 00841823109651 ()
BF10R-SP21X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109637

No Description
Ad-Tech Medical Instrument Corporation
2
In Commercial Distribution

  • 00841823109637 ()
BF12R-SP05X-0BH

  • Depth electrode

Macro Depth Electrode - 00841823109620

No Description
Ad-Tech Medical Instrument Corporation
1
In Commercial Distribution

  • 00841823109620 ()
BF12R-SP21X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109613

No Description
Ad-Tech Medical Instrument Corporation
0
In Commercial Distribution

  • 00841823109613 ()
BF12R-SP61X-0C3

  • Depth electrode

Depth Electrode - 00841823109576

No Description
Ad-Tech Medical Instrument Corporation
MM31A-SP53X-000
In Commercial Distribution

  • 00841823109576 ()
MM31A-SP53X-000

  • Depth electrode

Depth Electrode - 00841823109569

No Description
Ad-Tech Medical Instrument Corporation
MM29A-SP52X-000
In Commercial Distribution

  • 00841823109569 ()
MM29A-SP52X-000

  • Depth electrode

Depth Electrode - 00841823109552

No Description
Ad-Tech Medical Instrument Corporation
MM32D-SP05X-000
In Commercial Distribution

  • 00841823109552 ()
MM32D-SP05X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109514

No Description
Ad-Tech Medical Instrument Corporation
SD07R-SP45X-0T0
In Commercial Distribution

  • 00841823109514 ()
SD07R-SP45X-0T0

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109507

No Description
Ad-Tech Medical Instrument Corporation
SD06R-SP45X-000
In Commercial Distribution

  • 00841823109507 ()
SD06R-SP45X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109491

No Description
Ad-Tech Medical Instrument Corporation
SD16R-SP05X-000
In Commercial Distribution

  • 00841823109491 ()
SD16R-SP05X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109484

No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP45X-0T1
In Commercial Distribution

  • 00841823109484 ()
SD14R-SP45X-0T1

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109460

No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP03X-000
In Commercial Distribution

  • 00841823109460 ()
SD14R-SP03X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109446

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP45X-000
In Commercial Distribution

  • 00841823109446 ()
SD12R-SP45X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109422

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP09X-000
In Commercial Distribution

  • 00841823109422 ()
SD12R-SP09X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109408

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP05X-000
In Commercial Distribution

  • 00841823109408 ()
SD12R-SP05X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109392

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP03X-000
In Commercial Distribution

  • 00841823109392 ()
SD12R-SP03X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109385

No Description
Ad-Tech Medical Instrument Corporation
SD11R-SP45X-0T0
In Commercial Distribution

  • 00841823109385 ()
SD11R-SP45X-0T0

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109378

No Description
Ad-Tech Medical Instrument Corporation
SD10R-SP45X-000
In Commercial Distribution

  • 00841823109378 ()
SD10R-SP45X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109354

No Description
Ad-Tech Medical Instrument Corporation
SD10R-SP05X-000
In Commercial Distribution

  • 00841823109354 ()
SD10R-SP05X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109347

No Description
Ad-Tech Medical Instrument Corporation
SD10R-SP03X-000
In Commercial Distribution

  • 00841823109347 ()
SD10R-SP03X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109330

No Description
Ad-Tech Medical Instrument Corporation
SD09R-SP45X-0T0
In Commercial Distribution

  • 00841823109330 ()
SD09R-SP45X-0T0

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109323

No Description
Ad-Tech Medical Instrument Corporation
SD08R-SP45X-000
In Commercial Distribution

  • 00841823109323 ()
SD08R-SP45X-000

  • Depth electrode

3mm Cueva Electrode Kit - 00841823100863

No Description
Ad-Tech Medical Instrument Corporation
CNE1-3KDINX
In Commercial Distribution

  • 90841823100866 ()
  • 00841823100863 ()
CNE1-3KDINX

  • Depth electrode

2mm Cueva Electrode Kit - 00841823100856

No Description
Ad-Tech Medical Instrument Corporation
CNE1-2KDINX
In Commercial Distribution

  • 90841823100859 ()
  • 00841823100856 ()
CNE1-2KDINX

  • Depth electrode
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