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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Size: X-Small (waist circumference measured 2" below belly button: 22 - 26 inches). The Aretech Premium Harness is designed for use with Aretech products.
ARETECH, LLC
AH-XS
In Commercial Distribution

  • 00850018836098 ()


  • Gait rehabilitation system harness
Size: Pediatric (waist circumference measured 2" below belly button: 22 - 26 inches). The Aretech Premium Harness is designed for use with Aretech products.
ARETECH, LLC
AH-0P
In Commercial Distribution

  • 00850018836081 ()


  • Gait rehabilitation system harness
Size: Toddler (waist circumference measured 2" below belly button: 20 - 23 inches). The Aretech Premium Harness is designed for use with Aretech products.
ARETECH, LLC
AH-0T
In Commercial Distribution

  • 00850018836074 ()


  • Gait rehabilitation system harness
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
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
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
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
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw - Pack of 3
In Commercial Distribution

  • 37290114061408 ()
700-001330-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega Drive Headstage Kit
In Commercial Distribution

  • 27290114064532 ()
750-020021-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage
In Commercial Distribution

  • 27290114064525 ()
NOW-020021-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots
In Commercial Distribution

  • 27290114064518 ()
NOW-DFF000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage + 1 basic stimulation Slot
In Commercial Distribution

  • 27290114064501 ()
NOW-DF0000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav Drive Headstage
In Commercial Distribution

  • 27290114064495 ()
700-026000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav Drive Headstage
In Commercial Distribution

  • 27290114064488 ()
NNW-026000-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Long Bengun
In Commercial Distribution

  • 27290114064112 ()
700-020874-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Long Bengun
In Commercial Distribution

  • 27290114064105 ()
700-020847-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Long Bengun
In Commercial Distribution

  • 27290114064099 ()
700-020832-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Long Bengun
In Commercial Distribution

  • 27290114064082 ()
700-020834-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Renishaw Non-XY frame Mechanical Set KIT
In Commercial Distribution

  • 27290114064044 ()
700-020050-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with AutoClavable Drive Headstage (AutoClavable)
In Commercial Distribution

  • 27290114063863 ()
NOW-020025-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage
In Commercial Distribution

  • 27290114063856 ()
NOW-020021-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with AutoClavable Drive Headstage (AutoClavable)
In Commercial Distribution

  • 27290114063306 ()
NSW-006008-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with MER Headstage
In Commercial Distribution

  • 27290114063276 ()
NNW-025023-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EMG HeadBox Kit
In Commercial Distribution

  • 27290114063214 ()
750-020013-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECOG HeadBox Kit
In Commercial Distribution

  • 27290114063207 ()
750-020016-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots
In Commercial Distribution

  • 27290114063191 ()
NOW-DFF000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage + 1 basic stimulation Slot
In Commercial Distribution

  • 27290114063184 ()
NOW-DF0000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with NeuroFortis Drive Headstage + 2 basic stimulation Slots
In Commercial Distribution

  • 27290114063177 ()
NOW-NFF000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with NeuroFortis Drive Headstage + 1 basic stimulation Slot
In Commercial Distribution

  • 27290114063160 ()
NOW-NF0000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart Autoclavable Drive Headstage KIT (Autoclavable)
In Commercial Distribution

  • 27290114063153 ()
700-026008-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart MER Headstage KIT
In Commercial Distribution

  • 27290114063146 ()
700-026009-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroFortis NeuroSmart Drive Headstage KIT
In Commercial Distribution

  • 27290114063139 ()
700-026010-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart with NeuroFortis Drive Headstage
In Commercial Distribution

  • 27290114063016 ()
NSW-026010-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega Autoclavable Drive Headstage KIT (Autoclavable)
In Commercial Distribution

  • 27290114062484 ()
750-020025-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega Drive Headstage Kit
In Commercial Distribution

  • 27290114062477 ()
750-020021-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav Drive Headstage Kit
In Commercial Distribution

  • 27290114062460 ()
700-026000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega MER Headstage KIT
In Commercial Distribution

  • 27290114062453 ()
750-020024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav MER Headstage KIT
In Commercial Distribution

  • 27290114062446 ()
700-025023-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroFortis Neuro Omega Drive Headstage KIT
In Commercial Distribution

  • 27290114062439 ()
750-020070-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with NeuroFortis Drive Headstage
In Commercial Distribution

  • 27290114062422 ()
NOW-020070-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with Autoclavable Drive Headstage (AutoClavable)
In Commercial Distribution

  • 27290114062415 ()
NNW-006008-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with NeuroNav Drive Headstage
In Commercial Distribution

  • 27290114062408 ()
NNW-026000-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with NeuroFortis Drive Headstage
In Commercial Distribution

  • 27290114062392 ()
NNW-006010-55

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Universal LeadConfirm cable holder silicone sleeve - Pack of 5
In Commercial Distribution

  • 27290114061388 ()
341-011308-05

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Universal DBS holder silicone sleeve - Pack of 5
In Commercial Distribution

  • 27290114061371 ()
341-011305-05

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NexDrive Electrode Holder - Pack of 2
In Commercial Distribution

  • 27290114061166 ()
700-000316-02

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061159 ()
700-021507-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061142 ()
700-021508-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061135 ()
700-020874-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
4
In Commercial Distribution

  • 27290114061128 ()
700-020847-00

  • Depth electrode
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