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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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Codonics Safe Label System®(SLS) 500i Point of Care Station - 00814905020236

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items-140C
CODONICS INC.
500i PCS -140C
In Commercial Distribution

  • 00814905020236 ()


  • Parenteral-nutrition management software

Codonics Safe Label System®(SLS) 500i Point of Care Station - 00814905020229

Integrated computer based barcode scan & print system automatically to verify drugs & print labels of prepared drugs & other items
CODONICS INC.
500i PCS
In Commercial Distribution

  • 00814905020229 ()


  • Parenteral-nutrition management software

Spacelabs - 10841522108792

OPTION, SPACELABS SPO2, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
UV SL Command Module
Not in Commercial Distribution

  • 10841522108792 ()
R-91496-U

  • Patient monitoring system module, multifunction

Spacelabs - 10841522108785

OPTION, NELLCOR OXIMAX SPO2, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
UV SL Command Module
Not in Commercial Distribution

  • 10841522108785 ()
R-91496-N

  • Patient monitoring system module, multifunction

UltraviewSL - 10841522108778

OPTION, MASIMO SPO2, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
91496
Not in Commercial Distribution

  • 10841522108778 ()
R-91496-M

  • Patient monitoring system module, multifunction

UltraviewSL - 10841522107788

91496 UVSL COMMAND MODULE - NELLCOR
SPACELABS HEALTHCARE (WASHINGTON), INC
91496
Not in Commercial Distribution

  • 10841522107788 ()
L-91496-N

  • Patient monitoring system module, multifunction

UltraviewSL - 10841522107771

91496 UVSL COMMAND MODULE - MASIMO
SPACELABS HEALTHCARE (WASHINGTON), INC
91496
Not in Commercial Distribution

  • 10841522107771 ()
L-91496-M

  • Patient monitoring system module, multifunction

Ultraview SL - 10841522106439

OPTION,SPACELABS SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
Ultraview SL®
In Commercial Distribution

  • 10841522106439 ()
91496-U

  • Patient monitoring system module, multifunction

Ultraview SL - 10841522106422

OPTION,NELLCOR OXIMAX SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
Ultraview SL®
In Commercial Distribution

  • 10841522106422 ()
91496-N

  • Patient monitoring system module, multifunction

Ultraview SL - 10841522106415

OPTION, MASIMO SET SPO2
SPACELABS HEALTHCARE (WASHINGTON), INC
UV SL Command Module
In Commercial Distribution

  • 10841522106415 ()
91496-M

  • Patient monitoring system module, multifunction

CAPS - B702P31C0

Lightweight, portable, state of the art three-component force platform, measuring the vertical ground reaction force and its point of application (CoP). Its large surface allows for any stance. It is sensitive enough to pick up the changes in the vertical ground reaction force produced by the beating of the heart and the blood ejection in the aorta (including the modulation produced by the breathing cycle), while the subject is standing on the top surface. It satisfies the International Society for Posture and Gait Research (ISPGR) recommendations for clinical posturography. It is intended to be used as aid in fall risk screening; posturography (static and dynamic); weight, balance, and postural control assessment; mechanography; physical performance investigations; and objective tracking of treatment efficacy and disease progress. Covered by one or more US patents.
VESTIBULAR TECHNOLOGIES, LLC
Professional
In Commercial Distribution

  • B702P31C0 ()
P31C

  • Biomechanical function analysis/interactive rehabilitation system
  • Posturography system
  • Posturography system platform
  • Stand-on floor scale, electronic

QuickScan 2000 (Windows 2000) Software and Computer, Version 2.01 - M52516790000

No Description
HELENA LABORATORIES CORPORATION
1679000
In Commercial Distribution

  • M52516790000 ()


  • Densitometry analyser IVD

Soan - 03760349805335

1 Soan handpiece 1 wireless pedal 1 battery charger 1 power supply, 5 containers 1 user manual 2 boxes of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521)
DENTALHITEC
SOAN1
In Commercial Distribution

  • 03760349809951 ()
  • 03760349805335 ()
SOAN1

  • Dental computer assisted anaesthesia injection unit
  • Dental syringe needle, single-use

OmniME - 00858703006320

Multi-exercise respiratory therapy device with OmniFlow software and sensor, and Synchrony software, electrodes, and sensing devices
ACCELERATED CARE PLUS CORP
100MTS
In Commercial Distribution

  • 00858703006320 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical

OmniFlow Therapy System - 00858703006276

Software and sensor designed to provide visual feedback to respiratory patients.
ACCELERATED CARE PLUS CORP
100FLO
In Commercial Distribution

  • 00858703006276 ()


  • Bioelectrical signal analysis software
  • Biomechanical function analysis/interactive rehabilitation system
  • Monitoring spirometer, mechanical

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

Pinestar Technology Inc - 00850021301460

Jumbo Flood Phantom
PINESTAR TECHNOLOGY, INC.
NMC-76801
In Commercial Distribution

  • 00850021301460 ()


  • Nuclear medicine phantom, flood source

Pinestar Technology Inc - 00850021301453

Flood Phantom
PINESTAR TECHNOLOGY, INC.
76-801
In Commercial Distribution

  • 00850021301453 ()


  • Nuclear medicine phantom, flood source

RadQual - 00850020470051

Square 12" x 12" Phantom Co 57
RADQUAL, LLC
BM55
In Commercial Distribution

  • 00850020470051 ()


  • Nuclear medicine phantom, flood source

RadQual - 00850020470044

Rect 10" x 16" Phantom Co 57
RADQUAL, LLC
BM07
In Commercial Distribution

  • 00850020470044 ()


  • Nuclear medicine phantom, flood source

RadQual - 00850020470037

Square Digirad Phantom Co 57
RADQUAL, LLC
BM05
In Commercial Distribution

  • 00850020470037 ()


  • Nuclear medicine phantom, flood source

RadQual - 00850020470020

Rect 14" x 18" Phantom Co 57
RADQUAL, LLC
BM04
In Commercial Distribution

  • 00850020470020 ()


  • Nuclear medicine phantom, flood source

RadQual - 00850020470006

Rect 18" x24" Phantom Co 57
RADQUAL, LLC
BM01
In Commercial Distribution

  • 00850020470006 ()


  • Nuclear medicine phantom, flood source

Steadys-Step - 04650075332078

System is intended for objective gait analysis and biofeedback gait training based on EMG and IMU (Inertial Measurement Unit) data obtained with inertial sensors.
NEUROSOFT, OOO
Steadys-Step
In Commercial Distribution

  • 04650075332078 ()


  • Kinesiology/electromyographic sensor set

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

Sanders Medical Products - 00850055164017

No Description
Sanders Medical Products, Inc.
PET-LINE
In Commercial Distribution

  • 00850055164017 ()


  • Nuclear medicine phantom, line source

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™ Surgical Processor CP1150S - 09321502046367

N/A
COCHLEAR LIMITED
P1648881
In Commercial Distribution

  • 09321502046367 ()
P1648881

  • 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

NeuroField X3000 - 00860410000300

Pulsed Electromagnetic Field (pEMF) generator for use with NeuroField Software Suite. Stimulation unit for low-intensity neurofeedback.
NEUROFIELD, INC.
17
In Commercial Distribution

  • 00860410000300 ()


  • Kinesiology/electromyographic sensor set

Flood Phantom - 00718175000540

Flood Phantom, Rectangular, Fillable
BIODEX MEDICAL SYSTEMS, INC.
243-054
In Commercial Distribution

  • 00718175000540 ()
243-054

  • Nuclear medicine phantom, flood source

N/A - 00852423006240

Adapter for 7400 Disposable Lead Wire Electrodes
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
7100
In Commercial Distribution

  • 00852423006240 ()
7100

  • Kinesiology/electromyographic sensor set

N/A - 00852423006226

6’ Electrode Lead Wire Set
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
5338
In Commercial Distribution

  • 00852423006226 ()
5338

  • Kinesiology/electromyographic sensor set

Pathway - 00852423006134

Pathway® TR-10C Single Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-10C
In Commercial Distribution

  • 00852423006134 ()
8615

  • Kinesiology/electromyographic sensor set

SPINE KIT – 3 WISE - 08051122041084

The Showmotion SPINE 3 kit includes 3 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the spine and the head.
NCS LAB SRL
SHWM01S3
In Commercial Distribution

  • 08051122041084 ()


  • Kinesiology/electromyographic sensor set

SPINE KIT – 2 WISE - 08051122041077

The Showmotion SPINE 2 kit includes 2 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the spine.
NCS LAB SRL
SHWM01S2
In Commercial Distribution

  • 08051122041077 ()


  • Kinesiology/electromyographic sensor set
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