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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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DEPTHALON® - 00650551095804

MICROWIRE DEPTHALON ELECTRODE, 16 MICROWIRE CONTACTS, 2 SHIELDED INLINE TAILS
PMT CORPORATION
2104-04-16-03-102
In Commercial Distribution

  • 00650551095804 ()

  • Microwire Diameter 40 Micrometer
  • Main Tube Length 30 Centimeter
  • Contact Size 2 Millimeter
2104-04-16-03-102

  • Depth electrode

DEPTHALON® - 00650551095798

MICROWIRE DEPTHALON ELECTRODE, 32 MICROWIRE CONTACTS, 3 SHIELDED INLINE TAILS
PMT CORPORATION
2104-04-16-02-053
In Commercial Distribution

  • 00650551095798 ()

  • Microwire Diameter 40 Micrometer
  • Main Tube Length 30 Centimeter
  • Contact Size 2 Millimeter
2104-04-16-02-053

  • Depth electrode

DEPTHALON® - 00650551095781

MICROWIRE DEPTHALON ELECTRODE, 32 MICROWIRE CONTACTS, 3 SHIELDED INLINE TAILS
PMT CORPORATION
2104-04-16-02-052
In Commercial Distribution

  • 00650551095781 ()

  • Microwire Diameter 40 Micrometer
  • Main Tube Length 30 Centimeter
  • Contact Size 2 Millimeter
2104-04-16-02-052

  • Depth electrode

DEPTHALON® - 00650551095774

MICROWIRE DEPTHALON ELECTRODE, 8 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-00-08-009
In Commercial Distribution

  • 00650551095774 ()

  • Microwire Diameter 25 Micrometer
  • Main Tube Length 15 Centimeter
2104-00-08-009

  • 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 - 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

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_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

ACUSON Origin Diagnostic Ultrasound System - 04056869996295

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

  • 04056869996295 ()


  • General-purpose ultrasound imaging system

Symbia S Series - 04056869001166

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

  • 04056869001166 ()


  • 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 125º Short Neck Collared Hip Stem - 09348215024192

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1826
In Commercial Distribution

  • 09348215024192 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024185

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1626
In Commercial Distribution

  • 09348215024185 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024178

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1526
In Commercial Distribution

  • 09348215024178 ()


  • Coated femoral stem prosthesis, modular

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

Origin Lateral Offset Collared Hip Stem - 09348215017798

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1303
In Commercial Distribution

  • 09348215017798 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017781

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1203
In Commercial Distribution

  • 09348215017781 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017774

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1103
In Commercial Distribution

  • 09348215017774 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017767

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1003
In Commercial Distribution

  • 09348215017767 ()


  • Coated femoral stem prosthesis, modular

Origin Lateral Offset Collared Hip Stem - 09348215017750

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0903
In Commercial Distribution

  • 09348215017750 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013189

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1304
In Commercial Distribution

  • 09348215013189 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013172

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1204
In Commercial Distribution

  • 09348215013172 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013165

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1104
In Commercial Distribution

  • 09348215013165 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013158

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1004
In Commercial Distribution

  • 09348215013158 ()


  • Coated femoral stem prosthesis, modular

Origin Coxa Vara Hip Stem - 09348215013141

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0904
In Commercial Distribution

  • 09348215013141 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024161

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1426
In Commercial Distribution

  • 09348215024161 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024154

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1326
In Commercial Distribution

  • 09348215024154 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024147

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1226
In Commercial Distribution

  • 09348215024147 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024130

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1126
In Commercial Distribution

  • 09348215024130 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024123

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1026
In Commercial Distribution

  • 09348215024123 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024116

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0926
In Commercial Distribution

  • 09348215024116 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024109

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1825
In Commercial Distribution

  • 09348215024109 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024093

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1625
In Commercial Distribution

  • 09348215024093 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024086

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1525
In Commercial Distribution

  • 09348215024086 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Hip Stem - 09348215024079

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1425
In Commercial Distribution

  • 09348215024079 ()


  • Coated femoral stem prosthesis, modular
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