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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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E-LINK Myo-EX GX2 EMG Sensor - 05060481692458

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX2 sensor is used with disposable/reusable electrodes and applied where there is need to cover a larger surface area, for example on the quad muscles.. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
BIOMETRICS LIMITED
GX2
In Commercial Distribution

  • 05060481692458 ()


  • Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX1 EMG Sensor - 05060481692441

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX1 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
BIOMETRICS LIMITED
GX1
In Commercial Distribution

  • 05060481692441 ()


  • Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX4 EMG Sensor - 05060481690515

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX4 sensor is used with disposable/reusable electrodes and applied where there is need to cover a larger surface area, for example on the quad muscles.. Metal connector for use with E-LINK X4 MkI or MkII Interface Unit with metal connectors. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
BIOMETRICS LIMITED
GX4
In Commercial Distribution

  • 05060481690515 ()
GX4 metal connector

  • Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX3 EMG Sensor - 05060481690508

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX3 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. Metal connector for use with E-LINK X4 MkI or MkII Interface Unit with metal connectors. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
BIOMETRICS LIMITED
GX3
In Commercial Distribution

  • 05060481690508 ()
GX3 metal connector

  • Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX5 Wireless EMG Sensor - 05060481690157

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX5 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
GX5
In Commercial Distribution

  • 05060481690157 ()


  • Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX4 EMG Sensor - 05060481690119

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX4 sensor is used with disposable/reusable electrodes and applied where there is need to cover a larger surface area, for example on the quad muscles.. Plastic connector for use with E-LINK X4 MkIV Interface Unit with plastic connectors. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
GX4
In Commercial Distribution

  • 05060481690119 ()
GX4 plastic connector

  • Kinesiology/electromyographic sensor set

E-LINK Myo-EX GX3 EMG Sensor - 05060481690102

Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX3 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. Plastic connector for use with E-LINK X4 MkIV Interface Unit with plastic connectors. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
GX3
In Commercial Distribution

  • 05060481690102 ()
GX3 plastic connector

  • Kinesiology/electromyographic sensor set

Dual EMG Electrodes - 10816271020084

Solid Gel Ag/AgCl Dual EMG Electrodes 210 pieces per case
Noraxon U.S.A., Inc.
271SCASE
In Commercial Distribution

  • 10816271020084 ()
271SCASE

  • Kinesiology/electromyographic sensor set

DMC-EZ - 00850018049139

DICOM Media Creator - USB Thermal
Storage Solutions Technology Group Inc.
DMC-EZ USB
In Commercial Distribution

  • 00850018049139 ()
DMC-EZ USB

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049122

DICOM Media Creator - 575 Inkjet
Storage Solutions Technology Group Inc.
DMC-EZ 575
In Commercial Distribution

  • 00850018049122 ()
DMC-EZ 575

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049054

DICOM Media Creator - FLUP
Storage Solutions Technology Group Inc.
DMC-EZ FLUP
In Commercial Distribution

  • 00850018049054 ()
DMC-EZ FLUP

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049047

DICOM Media Creator - 8500 Thermal
Storage Solutions Technology Group Inc.
DMC-EZ 8500
In Commercial Distribution

  • 00850018049047 ()
DMC-EZ 8500

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049030

DICOM Media Creator - 3600 Thermal
Storage Solutions Technology Group Inc.
DMC-EZ 3600
In Commercial Distribution

  • 00850018049030 ()
DMC-EZ 3600

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049023

DICOM Media Creator - 250 Inkjet
Storage Solutions Technology Group Inc.
DMC-EZ 250
In Commercial Distribution

  • 00850018049023 ()
DMC-EZ 250

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049016

DICOM Media Creator - 55 Inkjet
Storage Solutions Technology Group Inc.
DMC-EZ 55
In Commercial Distribution

  • 00850018049016 ()
DMC-EZ 55

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049009

DICOM Media Creator - 25 Inkjet
Storage Solutions Technology Group Inc.
DMC-EZ 25
In Commercial Distribution

  • 00850018049009 ()
DMC-EZ 25

  • DICOM image data disc-recording unit

Cochlear™ Surgical Processor CP1150S - 09321502046367

N/A
COCHLEAR LIMITED
P1648881
In Commercial Distribution

  • 09321502046367 ()
P1648881

  • Cochlear implant intraoperative electrophysiological transceiver

Cochlear™ CP1110S Surgical Coil, 2m - 09321502073110

Hearing Implant Accessory
COCHLEAR LIMITED
2m
In Commercial Distribution

  • 09321502073110 ()
P1998830

  • Cochlear implant intraoperative electrophysiological transceiver

Cochlear™ Surgical Processing Unit - 09321502065252

Intraoperative Sound Processor
COCHLEAR LIMITED
CP1110S
In Commercial Distribution

  • 09321502065252 ()
P1840761

  • Cochlear implant intraoperative electrophysiological transceiver

Cochlear™ CP1110S Surgical Coil - 09321502054348

Hearing Implant Accessory
COCHLEAR LIMITED
N/A
In Commercial Distribution

  • 09321502054348 ()
P1749715

  • Cochlear implant intraoperative electrophysiological transceiver
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