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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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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

NeuroNav with MER Headstage - 27290114060879

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

  • 27290114060879 ()
NNW-025023-55

  • Depth electrode

Neuro Omega with Neuro Omega drive + 2 basic stimulation Slots - 27290114060787

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega drive + 2 basic stimulation Slots
In Commercial Distribution

  • 27290114060787 ()
NOW-DFF000-00

  • 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

Neuro Omega with NeuroFortis drive + 2 basic stimulation Slots - 27290114060763

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with NeuroFortis drive + 2 basic stimulation Slots
In Commercial Distribution

  • 27290114060763 ()
NOW-NFF000-00

  • Depth electrode

Neuro Omega with NeuroFortis drive + 1 basic stimulation Slot - 27290114060756

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

  • 27290114060756 ()
NOW-NF0000-00

  • Depth electrode

NeuroSmart Autoclavable Drive Headstage KIT - 27290114060596

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

  • 27290114060596 ()
700-026008-00

  • Depth electrode

NeuroSmart MER HeadStage KIT - 27290114060589

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

  • 27290114060589 ()
700-026009-00

  • Depth electrode

NeuroFortis NeuroSmart Drive HeadStage KIT - 27290114060572

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

  • 27290114060572 ()
700-026010-00

  • 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

CRW Non-XY frame Mechanical Set KIT - 27290016450952

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

  • 27290016450952 ()
700-020834-00

  • 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

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

Frame adapter thumb screw - Pack of 3 - 37290114061408

No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw - Pack of 3
In Commercial Distribution

  • 37290114061408 ()
700-001330-03

  • Depth electrode

inFlow Intraurethral Valve-Pump - 08625630003034

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

  • 08625630003034 ()
203511 SD

  • Intraurethral valve/pump

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

inFlow Intraurethral Valve-Pump - 08625630003002

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

  • 08625630003002 ()

  • Length: 60 Millimeter
  • Length: 55 Millimeter
  • Length: 50 Millimeter
  • Length: 45 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
203511

  • Intraurethral valve/pump

inFlow Device - 00862563003146

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003146 ()
203511-60

  • Intraurethral valve/pump

inFlow Device - 00862563003139

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003139 ()
203511-55

  • Intraurethral valve/pump

inFlow Device - 00862563003122

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003122 ()
203511-50

  • Intraurethral valve/pump

inFlow Device - 00862563003115

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003115 ()
203511-45

  • Intraurethral valve/pump

inFlow Device - 00862563003108

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003108 ()
203511-40

  • Intraurethral valve/pump

inFlow Device - 00862563003092

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003092 ()
203511-35

  • Intraurethral valve/pump

inFlow Device - 00862563003085

Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003085 ()
203511-30

  • Intraurethral valve/pump

inFlow Sizing Device - 00862563003078

Urethral measurement device, female.
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003078 ()
203511-SD

  • Intraurethral valve/pump

Origin Stem Size 20 Template - 09348215055974

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-170
In Commercial Distribution

  • 09348215055974 ()


  • Surgical implant template, reusable

Origin Stem Size 18 Template - 09348215055967

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-168
In Commercial Distribution

  • 09348215055967 ()


  • Surgical implant template, reusable

Origin Stem Size 16 Template - 09348215055950

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-166
In Commercial Distribution

  • 09348215055950 ()


  • Surgical implant template, reusable

Origin Stem Size 15 Template - 09348215055943

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-165
In Commercial Distribution

  • 09348215055943 ()


  • Surgical implant template, reusable

Origin Stem Size 14 Template - 09348215055936

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-164
In Commercial Distribution

  • 09348215055936 ()


  • Surgical implant template, reusable

Origin Stem Size 13 Template - 09348215055929

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-163
In Commercial Distribution

  • 09348215055929 ()


  • Surgical implant template, reusable

Origin Stem Size 12 Template - 09348215055912

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-162
In Commercial Distribution

  • 09348215055912 ()


  • Surgical implant template, reusable

Origin Stem Size 11 Template - 09348215055905

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-161
In Commercial Distribution

  • 09348215055905 ()


  • Surgical implant template, reusable

Origin Stem Size 10 Template - 09348215055899

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-160
In Commercial Distribution

  • 09348215055899 ()


  • Surgical implant template, reusable

Origin Stem Size 9 Template - 09348215055882

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-159
In Commercial Distribution

  • 09348215055882 ()


  • Surgical implant template, reusable
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