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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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Origin 125º Short Neck Hip Stem - 09348215024062

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1325
In Commercial Distribution

  • 09348215024062 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024055

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1225
In Commercial Distribution

  • 09348215024055 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024048

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1125
In Commercial Distribution

  • 09348215024048 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024031

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1025
In Commercial Distribution

  • 09348215024031 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024024

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0925
In Commercial Distribution

  • 09348215024024 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215024017

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1806
In Commercial Distribution

  • 09348215024017 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215024000

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1606
In Commercial Distribution

  • 09348215024000 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023997

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1506
In Commercial Distribution

  • 09348215023997 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023980

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1406
In Commercial Distribution

  • 09348215023980 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023973

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1306
In Commercial Distribution

  • 09348215023973 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023966

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1206
In Commercial Distribution

  • 09348215023966 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023959

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1106
In Commercial Distribution

  • 09348215023959 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023942

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1006
In Commercial Distribution

  • 09348215023942 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Collared Hip Stem - 09348215023935

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0906
In Commercial Distribution

  • 09348215023935 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023928

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1805
In Commercial Distribution

  • 09348215023928 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023911

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1605
In Commercial Distribution

  • 09348215023911 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023904

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1505
In Commercial Distribution

  • 09348215023904 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023898

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1405
In Commercial Distribution

  • 09348215023898 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023881

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1305
In Commercial Distribution

  • 09348215023881 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023874

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1205
In Commercial Distribution

  • 09348215023874 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023867

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1105
In Commercial Distribution

  • 09348215023867 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023850

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1005
In Commercial Distribution

  • 09348215023850 ()


  • Coated femoral stem prosthesis, modular

Origin Short Neck Hip Stem - 09348215023843

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0905
In Commercial Distribution

  • 09348215023843 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215023836

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0803
In Commercial Distribution

  • 09348215023836 ()


  • Coated femoral stem prosthesis, modular

ACUSON Origin Diagnostic Ultrasound System - 04056869996295

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11668590
In Commercial Distribution

  • 04056869996295 ()


  • General-purpose ultrasound imaging system

Symbia E Dual Head System - 04056869001159

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10275879
In Commercial Distribution

  • 04056869001159 ()


  • Stationary gamma camera system

Symbia E Single Head System - 04056869002729

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10413009
In Commercial Distribution

  • 04056869002729 ()


  • Stationary gamma camera system

c.cam Imaging System - 04056869001272

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08419009
In Commercial Distribution

  • 04056869001272 ()
8419009..

  • Stationary gamma camera system

Symbia_Evo_Excel - 04056869001265

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910501
In Commercial Distribution

  • 04056869001265 ()


  • Stationary gamma camera system

Symbia_Evo - 04056869001258

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
10910500
In Commercial Distribution

  • 04056869001258 ()


  • Stationary gamma camera system

Symbia S Series - 04056869001166

No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
08717741
In Commercial Distribution

  • 04056869001166 ()


  • Stationary gamma camera system

G-EO - 07640174420032

Robotic-assisted gait trainer
Reha Technology AG
G-EO
In Commercial Distribution

  • 07640174420032 ()


  • Treadmill/elliptical gait rehabilitation system

G-EO System - 07640174420018

Robotic-assisted gait trainer
Reha Technology AG
G-EO System
In Commercial Distribution

  • 07640174420018 ()


  • Treadmill/elliptical gait rehabilitation system

ReWalk(TM) Rehabilitaiton - 00861803000327

Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical

ReStore - 00860001744507

The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical

QIAstat-Dx® Respiratory Panel - 04053228033905

No Description
QIAGEN GmbH
V1
In Commercial Distribution

  • 04053228033905 ()
691221

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

PMT® CORPORATION - SPHENOIDAL - 10650551092862

SPHENOIDAL ELECTRODE EEG CABLE 1.5MM SOCKET SET
PMT CORPORATION
2122
In Commercial Distribution

  • 10650551092862 ()
  • 00650551092865 ()
2122

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092855

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, 2 LOOSE CONNECTORS
PMT CORPORATION
2102-32-09
In Commercial Distribution

  • 10650551092855 ()
  • 00650551092858 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-09

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092848

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-05
In Commercial Distribution

  • 10650551092848 ()
  • 00650551092841 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.25 Inch
2102-32-05

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092831

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-03
In Commercial Distribution

  • 10650551092831 ()
  • 00650551092834 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092824

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2102-31-03
In Commercial Distribution

  • 10650551092824 ()
  • 00650551092827 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-31-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092817

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-03
In Commercial Distribution

  • 10650551092817 ()
  • 00650551092810 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-32-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092800

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2101-31-03
In Commercial Distribution

  • 10650551092800 ()
  • 00650551092803 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-31-03

  • Depth electrode

DEPTHALON® - 00650551139805

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-155
In Commercial Distribution

  • 00650551139805 ()

  • Main Tube Length 27 Centimeter
  • Spacing 6 Millimeter
  • Recording Depth 74 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-155

  • Depth electrode

DEPTHALON® - 00650551139799

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-146
In Commercial Distribution

  • 00650551139799 ()

  • Main Tube Length 27 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 65 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-146

  • Depth electrode

DEPTHALON® - 00650551139782

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-149
In Commercial Distribution

  • 00650551139782 ()

  • Main Tube Length 27 Centimeter
  • Spacing 4 Millimeter
  • Recording Depth 56 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-149

  • Depth electrode

DEPTHALON® - 00650551139775

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-145
In Commercial Distribution

  • 00650551139775 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 47 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-145

  • Depth electrode

DEPTHALON® - 00650551139768

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-148
In Commercial Distribution

  • 00650551139768 ()

  • Main Tube Length 27 Centimeter
  • Spacing 2 Millimeter
  • Recording Depth 38 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-148

  • Depth electrode

DEPTHALON® - 00650551139751

sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-144
In Commercial Distribution

  • 00650551139751 ()

  • Main Tube Length 27 Centimeter
  • Spacing 1 Millimeter
  • Recording Depth 29 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-144

  • Depth electrode

DEPTHALON® - 00650551139744

sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-08-148
In Commercial Distribution

  • 00650551139744 ()

  • Main Tube Length 27 Centimeter
  • Spacing 2 Millimeter
  • Recording Depth 30 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-08-148

  • Depth electrode
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