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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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DeguDent GmbH
Cergo Kiss Pellets Crystal CO / 7 St.
Not in Commercial Distribution

  • EDD153651303070 ()
  • EDD153651303078 ()
5365130307

  • Dental appliance fabrication material, ceramic
The ATLAS Patient Event Marker is an optional configuration of the ATLAS Neurophysiology System that allows the patient to mark an event in the Data Acquisition Software.
NEURALYNX, INC.
ATLAS Patient Event Marker
In Commercial Distribution

  • 00850011306192 ()
31-0604-0133

  • Electrical-only medical device connection cable, reusable
The ATLAS CHET Adapter is an optional configuration of the ATLAS Neurophysiology System that allows up to 4 clinical headstages to interface with the ATLAS Acquisition Amplifier.
NEURALYNX, INC.
ATLAS CHET ADAPTER
Not in Commercial Distribution

  • 00850011306154 ()
31-0602-0028

  • Electrical-only medical device connection cable, reusable
Kit includes: Norav Wireless ECG Acquisition Device NR3 (UDI: 7290110255381) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors.
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110255404 ()
NR1207E-K-00-E-B10-06

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254773) for Resting-ECG with AHA type labelling. Input cable with 10 Patient leads AHA type and Banana connectors.
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110254834 ()
NR1207E-K-00-U-B10-02

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110254766) for Resting-ECG with AHA type labelling. Input cable with 10 Patient leads AHA type and Banana connectors.
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110254827 ()
NR1207E-K-00-U-B10-01

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Snap connectors.
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110254810 ()
NR1207E-K-00-E-S10-01

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless ECG Acquisition Device NR2 (UDI: 7290110254759) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors.
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110254780 ()
NR1207E-K-00-E-B10-02

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Telemetry ECG Acquisition Device NR1 (UDI: 07290110253332) for Telemetry Resting-ECG Monitoring with AHA type labelling; Input cable with 5 Patient leads, AHA type labelling.
NORAV MEDICAL LTD.
NR314T Kit
In Commercial Distribution

  • 07290110254681 ()
NR314T-K-00-U-S5-01

  • Electrocardiographic ambulatory recorder
Kit includes: Norav Wireless ECG Acquisition Device NR1 (UDI: 7290110253097) for Resting-ECG with IEC type labelling. Input cable with 10 Patient leads IEC type and Banana connectors.
NORAV MEDICAL LTD.
NR1207-E Kit
In Commercial Distribution

  • 07290110253103 ()
NR1207E-K-00-E-B10-01

  • Electrocardiographic ambulatory recorder
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