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

  • 27290016450846 ()
NOW-020025-00

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

  • 27290016450839 ()
NOW-020021-00

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

  • 27290016450815 ()
700-021507-03

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

  • 27290016450242 ()
700-000316-02

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

  • 27290016450228 ()
700-026008-00

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

  • 27290016450211 ()
750-020025-00

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

  • 27290016450198 ()
750-020021-00

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

  • 27290016450174 ()
700-026000-00

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

  • 27290016450167 ()
750-020024-00

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

  • 27290016450150 ()
700-026009-00

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

  • 27290016450143 ()
700-025023-00

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

  • 27290016450136 ()
750-020070-00

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

  • 27290016450129 ()
700-026010-00

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

  • 27290016450105 ()
NOW-020070-00

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

  • 27290016450099 ()
NSW-006008-55

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

  • 27290016450082 ()
NSW-026010-55

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

  • 27290016450068 ()
NNW-006008-55

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

  • 27290016450051 ()
NNW-026000-55

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

  • 27290014954100 ()
700-021508-00

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

  • 27290014954094 ()
700-020874-00

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

  • 58100013407418 ()
  • 18100013407427 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness
BELT
E.M. ADAMS, INC.
EP26-63375-1
Not in Commercial Distribution

  • 58100013407395 ()
  • 18100013407403 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness
BELT
E.M. ADAMS, INC.
EP26-63350XL-1
Not in Commercial Distribution

  • 58100013407371 ()
  • 18100013407380 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness
BELT
E.M. ADAMS, INC.
EP26-63350-1
Not in Commercial Distribution

  • 58100013407357 ()
  • 18100013407366 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness
BELT
E.M. ADAMS, INC.
EP26-63340XL-1
Not in Commercial Distribution

  • 58100013407333 ()
  • 18100013407342 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness
Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle 2x72inch Yellow Latex Free Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT723
In Commercial Distribution

  • 10885632061646 ()
  • 20885632061643 ()


  • Gait rehabilitation system harness
Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle 2x54 Inch Yellow Latex Free Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT543
In Commercial Distribution

  • 10885632061622 ()
  • 20885632061629 ()


  • Gait rehabilitation system harness
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1800
In Commercial Distribution

  • M7161111818000 ()
111-18-1800

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1600
In Commercial Distribution

  • M7161111816000 ()
111-18-1600

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 15, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1500
In Commercial Distribution

  • M7161111815000 ()
111-18-1500

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 14, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1400
In Commercial Distribution

  • M7161111814000 ()
111-18-1400

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1300
In Commercial Distribution

  • M7161111813000 ()
111-18-1300

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 12, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1200
In Commercial Distribution

  • M7161111812000 ()
111-18-1200

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 11, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1100
In Commercial Distribution

  • M7161111811000 ()
111-18-1100

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 10, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1000
In Commercial Distribution

  • M7161111810000 ()
111-18-1000

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 9, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0900
In Commercial Distribution

  • M7161111809000 ()
111-18-0900

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 8, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-0800
In Commercial Distribution

  • M7161111808000 ()
111-18-0800

  • Press-fit femoral stem prosthesis
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11668590
In Commercial Distribution

  • 04056869996295 ()


  • General-purpose ultrasound imaging system
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-1803
In Commercial Distribution

  • 09348215036454 ()


  • Coated femoral stem prosthesis, modular
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