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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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DEPTHALON® - 00650551142621

DEPTH ELECTRODE, PLATINUM, 4 CONTACT, NON-STANDARD CONNECTOR
PMT CORPORATION
2102-04-002
In Commercial Distribution

  • 00650551142621 ()

  • Main Tube Length 22 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 17 Millimeter
  • Contact Length 2 Millimeter
2102-04-002

  • Depth electrode

DEPTHALON® - 00650551142478

DEPTH ELECTRODE, PLATINUM, 10 CONTACT, MINI CONNECTOR
PMT CORPORATION
2102-10-291
In Commercial Distribution

  • 00650551142478 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 33.5 Millimeter
  • Contact Length 2 Millimeter
2102-10-291

  • Depth electrode

DEPTHALON® - 00650551142188

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL, 37.25MM SPACING BETWEEN CONTACTS #8 AND #9
PMT CORPORATION
2102-16-135
In Commercial Distribution

  • 00650551142188 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 90 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-135

  • Depth electrode

DEPTHALON® - 00650551142171

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL, 27.25MM SPACING BETWEEN CONTACTS #8 AND #9
PMT CORPORATION
2102-16-134
In Commercial Distribution

  • 00650551142171 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-134

  • Depth electrode

DEPTHALON® - 00650551142126

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-157
In Commercial Distribution

  • 00650551142126 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 85 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-157

  • Depth electrode

DEPTHALON® - 00650551141846

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-147
In Commercial Distribution

  • 00650551141846 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.33 Millimeter
  • Recording Depth 81.95 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-147

  • Depth electrode

DEPTHALON® - 00650551141792

sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-150
In Commercial Distribution

  • 00650551141792 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 100 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-150

  • Depth electrode

DEPTHALON® - 00650551141785

sEEG, PLATINUM, 12 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-12-147
In Commercial Distribution

  • 00650551141785 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.33 Millimeter
  • Recording Depth 60.6 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-12-147

  • 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 - 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 - 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

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 - 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 - 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

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)

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

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

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 - 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

Symbia_Evo_Excel - 04056869001265

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

  • 04056869001265 ()


  • Stationary gamma camera system

Symbia E Dual Head System - 04056869001159

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

  • 04056869001159 ()


  • Stationary gamma camera system

Origin Lateral Offset Collared Hip Stem - 09348215017835

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1803
In Commercial Distribution

  • 09348215017835 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017828

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1603
In Commercial Distribution

  • 09348215017828 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017811

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1503
In Commercial Distribution

  • 09348215017811 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017804

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1403
In Commercial Distribution

  • 09348215017804 ()


  • Coated femoral stem prosthesis, modular
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