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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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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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