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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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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 AutoClavable Drive Headstage - 27290016450099

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

  • 27290016450099 ()
NSW-006008-55

  • 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

NeuroNav with NeuroNav Drive - 27290016450051

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

  • 27290016450051 ()
NNW-026000-55

  • Depth electrode

NeuroNav with NeuroFortis Drive - 27290016450044

NeuroNav system with NeuroFortis Drive : NeurFortis Drive requires sterilization before use.
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroNav with NeuroFortis Drive
In Commercial Distribution

  • 27290016450044 ()
NNW-006010-55

  • 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

DEPTHALON - 00650551025412

sEEG DEPTH ELECTRODE, 4 MACRO CONTACTS, 12.5 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-04-091-NS
In Commercial Distribution

  • 00650551025412 ()


  • Depth electrode

DEPTHALON - 00650551002659

SEEG, PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH, NON-STERILE
PMT CORPORATION
2102-16-185-NS
In Commercial Distribution

  • 00650551002659 ()


  • Depth electrode

DEPTHALON - 00650551002642

SEEG, PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH, NON-STERILE
PMT CORPORATION
2102-16-184-NS
In Commercial Distribution

  • 00650551002642 ()


  • Depth electrode

DEPTHALON - 00650551001140

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 41MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL. NON-STERILE
PMT CORPORATION
2102-16-177-NS
In Commercial Distribution

  • 00650551001140 ()


  • Depth electrode

DEPTHALON - 00650551000860

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 48MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL, NON-STERILE
PMT CORPORATION
2102-16-176-NS
In Commercial Distribution

  • 00650551000860 ()


  • Depth electrode

DEPTHALON - 00650551000853

SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 44.5MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL, NON-STERILE
PMT CORPORATION
2102-16-175-NS
In Commercial Distribution

  • 00650551000853 ()


  • Depth electrode

DEPTHALON - 00650551000471

MICROWIRE DEPTHALON ELECTRODE, 1.5MM CONTACTS MARCO CONTACT DIA., 8 MACRO CONTACTS, 16 MICROWIRE CONTACTS, 51.1MM RECORDING LENGTH, MINI CONNECTOR, NON-STERILE
PMT CORPORATION
2104-08-16-006-NS
In Commercial Distribution

  • 00650551000471 ()


  • Depth electrode

inFlow Intraurethral Valve-Pump - 08625630003027

Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump

inFlow Intraurethral Valve-Pump - 08625630003003

Urinary prosthesis, female, non-surgical -- Sizing Device
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003003 ()
203511 SD

  • Intraurethral valve/pump
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