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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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Alpine BioMed - 05704736002592

Power Supply Unit
Alpine Biomed ApS
9031D0303
Not in Commercial Distribution

  • 05704736002592 ()


  • Electromyograph

Alpine Biomed - 05704736002431

Tendon Hammer
Alpine Biomed ApS
9031E0402
Not in Commercial Distribution

  • 05704736002431 ()


  • Electromyograph

Alpine Biomed - 05704736002400

Calibrated Acoustic Screened Headset
Alpine Biomed ApS
9031E0268
Not in Commercial Distribution

  • 05704736002400 ()


  • Electromyograph

Alpine BioMed - 05704736002288

2-channel EMG/EP Amplifier with 1.7 m cable
Alpine Biomed ApS
9031C0503
Not in Commercial Distribution

  • 05704736002288 ()


  • Electromyograph

Alpine BioMed - 05704736001830

KEYPOINT WORKSTATION GE
Alpine Biomed ApS
9031A006503
Not in Commercial Distribution

  • 05704736001830 ()


  • Electromyograph

Alpine BioMed - 05704736001809

KEYPOINT WORKSTATION INT. 115 VOLT,US VER.W/O US SOFT.
Alpine Biomed ApS
9031A0065HA
Not in Commercial Distribution

  • 05704736001809 ()


  • Electromyograph

Alpine Biomed - 05704736000680

ADAPT,2MM M X 1.5MM M TP,BLACK
Alpine Biomed ApS
9030L1032
Not in Commercial Distribution

  • 05704736000680 ()


  • Electromyograph

Alpine Biomed - 05704736000284

Leadpoint Stimulus Adaptor
Alpine Biomed ApS
9013C0532
Not in Commercial Distribution

  • 05704736000284 ()


  • Electromyograph

Uroval - 00852523007062

The Uroval BRS System is used to record and display electromyogram (EMG )signals. In addition, the BRS System will determine latency time intervals of the bulbocavernosus reflex (BCR). The Uroval BRS System also has report generation capabilities. The Uroval BRS System uses a probe, with a single use disposable tip to evoke a BCR response and activate recording and timing of EMG signals. The Uroval BRS System uses pre-gelled surface electrodes to monitor the muscle activity.
UROVAL, INC.
BRS System
In Commercial Distribution

  • 00852523007062 ()
BRS01

  • Electromyograph

PillSense Receiver - 05391539210073

The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule. The PillSense Receiver interprets the data and displays a result message “Blood Detected” or “No Blood Detected”.
ENTERASENSE LIMITED
P00167-01FP
In Commercial Distribution

  • 05391539210073 ()


  • Gastrointestinal telemetric monitoring system receiver
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