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Company Name Brand Name GMDN Term 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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NeuroSmart with NeuroFortis Drive - 27290114060435

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

  • 27290114060435 ()
NSW-026010-55

  • Depth electrode

Libenger ZD frame Mechanical Set Kit - 27290016450990

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Libenger ZD frame Mechanical Set KIT
In Commercial Distribution

  • 27290016450990 ()
700-020847-00

  • Depth electrode

Leksell Non-XY frame Mechanical Set Kit - 27290016450976

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

  • 27290016450976 ()
700-020832-00

  • Depth electrode

Neuro Omega - 27290016450938

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EMG- recording with Full Stimulation Source
In Commercial Distribution

  • 27290016450938 ()
750-02J013-00

  • Depth electrode

Neuro Omega - 27290016450891

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG- Recording with Full Stimulation Source
In Commercial Distribution

  • 27290016450891 ()
750-02J016-00

  • Depth electrode

Neuro Omega - 27290016450877

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG Recording Kit
In Commercial Distribution

  • 27290016450877 ()
750-02A016-00

  • Depth electrode

Neuro Omega EEG Recording Kit - 27290016450853

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EEG Recording Kit
In Commercial Distribution

  • 27290016450853 ()
750-02A011-00

  • Depth electrode

Neuro Omega with AutoClavable Drive Headstage - 27290016450846

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

  • 27290016450846 ()
NOW-020025-00

  • Depth electrode

Neuro Omega with NeuroOmega Drive - 27290016450839

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

  • 27290016450839 ()
NOW-020021-00

  • Depth electrode

NexFrame Mechanical Set Kit - 27290016450815

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NexFrame Mechanical Set KIT
In Commercial Distribution

  • 27290016450815 ()
700-021507-03

  • Depth electrode

NexDrive Electrode Holder - 27290016450242

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

  • 27290016450242 ()
700-000316-02

  • Depth electrode

NeuroSmart Autoclavable Drive Headstage Kit - 27290016450228

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

  • 27290016450228 ()
700-026008-00

  • Depth electrode

Neuro Omega Autoclavable Drive Headstage KIT - 27290016450211

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

  • 27290016450211 ()
750-020025-00

  • Depth electrode

NeuroOmega Drive Headstage Kit - 27290016450198

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

  • 27290016450198 ()
750-020021-00

  • Depth electrode

NeuroNav Drive Headstage Kit - 27290016450174

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

  • 27290016450174 ()
700-026000-00

  • Depth electrode

Neuro Omega MER HeadStage KIT - 27290016450167

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

  • 27290016450167 ()
750-020024-00

  • Depth electrode

NeuroSmart MER HeadStage Kit - 27290016450150

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroSmart MER HeadStage Kit
In Commercial Distribution

  • 27290016450150 ()
700-026009-00

  • Depth electrode

NeuroNav MER HeadStage KIT - 27290016450143

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

  • 27290016450143 ()
700-025023-00

  • Depth electrode

NeuroFortis Neuro Omega Drive HeadStage KIT - 27290016450136

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

  • 27290016450136 ()
750-020070-00

  • Depth electrode

NeuroFortis NeuroSmart Drive HeadStage KIT - 27290016450129

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

  • 27290016450129 ()
700-026010-00

  • Depth electrode

Neuro Omega with NeuroFortis Drive - 27290016450105

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

  • 27290016450105 ()
NOW-020070-00

  • Depth electrode

NeuroSmart with NeuroFortis Drive - 27290016450082

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

  • 27290016450082 ()
NSW-026010-55

  • Depth electrode

NeuroNav with Autoclavable Drive Headstage - 27290016450068

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

  • 27290016450068 ()
NNW-006008-55

  • Depth electrode

Starfix frame Mechanical Set Kit - 27290014954100

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Starfix frame Mechanical Set KIT
In Commercial Distribution

  • 27290014954100 ()
700-021508-00

  • Depth electrode

Libenger RM frame Mechanical Set KIT - 27290014954094

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Libenger RM frame Mechanical Set KIT
In Commercial Distribution

  • 27290014954094 ()
700-020874-00

  • Depth electrode

E.M Adams co, inc. - 18100013407427

BELT
E.M. ADAMS, INC.
EP26-63391-1
Not in Commercial Distribution

  • 58100013407418 ()
  • 18100013407427 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407403

BELT
E.M. ADAMS, INC.
EP26-63375-1
Not in Commercial Distribution

  • 58100013407395 ()
  • 18100013407403 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407380

BELT
E.M. ADAMS, INC.
EP26-63350XL-1
Not in Commercial Distribution

  • 58100013407371 ()
  • 18100013407380 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407366

BELT
E.M. ADAMS, INC.
EP26-63350-1
Not in Commercial Distribution

  • 58100013407357 ()
  • 18100013407366 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407342

BELT
E.M. ADAMS, INC.
EP26-63340XL-1
Not in Commercial Distribution

  • 58100013407333 ()
  • 18100013407342 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

NexFrame Mechanical Set Kit - 27290114061159

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

  • 27290114061159 ()
700-021507-03

  • Depth electrode

Starfix frame Mechanical Set Kit - 27290114061142

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

  • 27290114061142 ()
700-021508-00

  • Depth electrode

Leibinger RM frame Mechanical Set Kit - 27290114061135

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

  • 27290114061135 ()
700-020874-00

  • Depth electrode

Leibinger ZD frame Mechanical Set Kit - 27290114061128

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

  • 27290114061128 ()
700-020847-00

  • Depth electrode

Leksell Non-XY frame Mechanical Set KIT - 27290114061111

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

  • 27290114061111 ()
700-020832-00

  • Depth electrode

CRW Non-XY frame Mechanical Set KIT - 27290114061104

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

  • 27290114061104 ()
700-020834-00

  • Depth electrode

NeuroSmart Autoclavable Drive Headstage Kit - 27290114060930

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 5
In Commercial Distribution

  • 27290114060930 ()
700-026008-00

  • Depth electrode

NeuroSmart with AutoClavable Drive Headstage - 27290114060916

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 5
In Commercial Distribution

  • 27290114060916 ()
NSW-006008-55

  • Depth electrode

NeuroNav with Autoclavable Drive Headstage - 27290114060909

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Rev. 5
In Commercial Distribution

  • 27290114060909 ()
NNW-006008-55

  • Depth electrode

Neuro Omega with Neuro Omega drive + 1 basic stimulation Slot - 27290114060770

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega drive + 1 basic stimulation Slot
In Commercial Distribution

  • 27290114060770 ()
NOW-DF0000-00

  • Depth electrode
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