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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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SYNCHROMED®II - 00763000422615

PUMP 8637-40 SM II 40ML EMAN SYMBL GRC
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00763000422615 ()


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED®II - 00763000422608

PUMP 8637-20 SM II 20ML EMAN SYMBL GRC
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00763000422608 ()


  • Implantable intrathecal infusion pump, programmable

DeRoyal - 00749756947657

GAIT BELT, WIPEABLE
DEROYAL INDUSTRIES, INC.
M5168-YL
In Commercial Distribution

  • 00749756947657 ()
M5168-YL

  • Gait rehabilitation system harness

DeRoyal - 00749756951784

GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2672-B
In Commercial Distribution

  • 50749756951789 ()
  • 00749756951784 ()
M2672-B

  • Gait rehabilitation system harness

DeRoyal - 00749756999274

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5164-YL
In Commercial Distribution

  • 50749756999279 ()
  • 00749756999274 ()
M5164-YL

  • Gait rehabilitation system harness

DeRoyal - 00749756977937

Kit W/Blanket and Gait Belt
DEROYAL INDUSTRIES, INC.
MK3045-UBLG
In Commercial Distribution

  • 50749756977932 ()
  • 00749756977937 ()
MK3045-UBLG

  • Gait rehabilitation system harness

Neuro Omega Drive Headstage Kit - 27290114064532

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

  • 27290114064532 ()
750-020021-00

  • Depth electrode

Neuro Omega with Neuro Omega Drive Headstage - 27290114064525

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

  • 27290114064525 ()
NOW-020021-00

  • Depth electrode

Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots - 27290114064518

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

Neuro Omega with Neuro Omega Drive Headstage + 1 basic stimulation Slot - 27290114064501

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

NeuroNav Drive Headstage - 27290114064495

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

  • 27290114064495 ()
700-026000-00

  • Depth electrode

NeuroNav Drive Headstage - 27290114064488

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

  • 27290114064488 ()
NNW-026000-55

  • Depth electrode

Leibinger RM frame Mechanical Set KIT - 27290114064112

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

  • 27290114064112 ()
700-020874-00

  • Depth electrode

Leibinger ZD frame Mechanical Set KIT - 27290114064105

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

  • 27290114064105 ()
700-020847-00

  • Depth electrode

Leksell Non-XY frame Mechanical Set KIT - 27290114064099

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

  • 27290114064099 ()
700-020832-00

  • Depth electrode

CRW Non-XY frame Mechanical Set KIT - 27290114064082

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

  • 27290114064082 ()
700-020834-00

  • Depth electrode

Renishaw Non-XY frame Mechanical Set KIT - 27290114064044

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

  • 27290114064044 ()
700-020050-00

  • Depth electrode

Neuro Omega with AutoClavable Drive Headstage (AutoClavable) - 27290114063863

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

  • 27290114063863 ()
NOW-020025-00

  • Depth electrode

Neuro Omega with Neuro Omega Drive Headstage - 27290114063856

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

  • 27290114063856 ()
NOW-020021-00

  • Depth electrode

NeuroSmart with AutoClavable Drive Headstage (AutoClavable) - 27290114063306

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

  • 27290114063306 ()
NSW-006008-55

  • Depth electrode

NeuroNav with MER Headstage - 27290114063276

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

  • 27290114063276 ()
NNW-025023-55

  • Depth electrode

Neuro Omega EMG HeadBox Kit - 27290114063214

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

  • 27290114063214 ()
750-020013-00

  • Depth electrode

Neuro Omega ECOG HeadBox Kit - 27290114063207

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

  • 27290114063207 ()
750-020016-00

  • Depth electrode

Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots - 27290114063191

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

Neuro Omega with Neuro Omega Drive Headstage + 1 basic stimulation Slot - 27290114063184

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

Neuro Omega with NeuroFortis Drive Headstage + 2 basic stimulation Slots - 27290114063177

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

Neuro Omega with NeuroFortis Drive Headstage + 1 basic stimulation Slot - 27290114063160

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

NeuroSmart Autoclavable Drive Headstage KIT (Autoclavable) - 27290114063153

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

  • 27290114063153 ()
700-026008-00

  • Depth electrode

NeuroSmart MER Headstage KIT - 27290114063146

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

  • 27290114063146 ()
700-026009-00

  • Depth electrode

NeuroFortis NeuroSmart Drive Headstage KIT - 27290114063139

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

  • 27290114063139 ()
700-026010-00

  • Depth electrode

NeuroSmart with NeuroFortis Drive Headstage - 27290114063016

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

  • 27290114063016 ()
NSW-026010-55

  • Depth electrode

Neuro Omega Autoclavable Drive Headstage KIT (Autoclavable) - 27290114062484

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

  • 27290114062484 ()
750-020025-00

  • Depth electrode

Neuro Omega Drive Headstage Kit - 27290114062477

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

  • 27290114062477 ()
750-020021-00

  • Depth electrode

NeuroNav Drive Headstage Kit - 27290114062460

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

  • 27290114062460 ()
700-026000-00

  • Depth electrode

Neuro Omega MER Headstage KIT - 27290114062453

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

  • 27290114062453 ()
750-020024-00

  • Depth electrode

NeuroNav MER Headstage KIT - 27290114062446

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

  • 27290114062446 ()
700-025023-00

  • Depth electrode

NeuroFortis Neuro Omega Drive Headstage KIT - 27290114062439

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

  • 27290114062439 ()
750-020070-00

  • Depth electrode

Neuro Omega with NeuroFortis Drive Headstage - 27290114062422

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

  • 27290114062422 ()
NOW-020070-00

  • Depth electrode

NeuroNav with Autoclavable Drive Headstage (AutoClavable) - 27290114062415

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

  • 27290114062415 ()
NNW-006008-55

  • Depth electrode

NeuroNav with NeuroNav Drive Headstage - 27290114062408

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

  • 27290114062408 ()
NNW-026000-55

  • Depth electrode
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