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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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Orthex P&C Software v1.2
VILEX IN TENNESSEE, INC.
ORTHEXRPS
In Commercial Distribution

  • 00841731118844 ()


  • External orthopaedic fixation frame calculation software
Orthex P&C Software
VILEX IN TENNESSEE, INC.
ORTHEXRPS
Not in Commercial Distribution

  • 00841731119209 ()


  • External orthopaedic fixation frame calculation software
HL-7 NEUROWORKBENCH INTERFACE
NIHON KOHDEN AMERICA, INC.
A/NWB-HL7NIS
In Commercial Distribution

  • 00841983103711 ()
A/NWB-HL7NIS

  • Medical networking interface unit
HL-7 INTERFACE FOR NEUROWORKBENCH SOFTWARE
NIHON KOHDEN AMERICA, INC.
A/NWB-HL7CS
In Commercial Distribution

  • 00841983103636 ()
A/NWB-HL7CS

  • Medical networking interface unit
It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation on the spot.
EMAY (HK) LIMITED
EMG-6L
In Commercial Distribution

  • 04897087206120 ()


  • Telemetric electrocardiographic ambulatory recorder
The Orpyx Hub is the bluetooth-cellular bridge that enables sensor data from the insole to be sent to the cloud as part of the Orpyx Customer Sensory Insole System. This package contains a replacement Orpyx Hub and product documentation such as a manual. The Orpyx Custom Sensory Insole system consists of a powered limb overload warning technology to provide real time notifications for pressure offloading. For wellness purposes the system also includes temperature sensors to monitor physiological parameters such as plantar foot skin temperature and motion sensors to measure activity. The Orpyx Custom Sensory Insole is fabricated from a foot impression. The Orpyx Custom Sensory Insole system is intended to act as an adjunct to standard footcare, not a replacement. It is designed for use throughout everyday activities. Orpyx Sensory Insoles system is indicated for people at risk of developing ulcers on the plantar aspect of the foot. The device is a prescription device and is not transferable to another person. The product does not diagnose or treat any conditions, it is meant to be used as an adjunct to current foot care practices.
Orpyx
OH000010
In Commercial Distribution

  • 10185571000554 ()


  • Medical networking interface unit
The Ethernet Switch is a fully managed switch designed for high-performance networking in enterprise environments.
NEURALYNX, INC.
Ethernet Switch
In Commercial Distribution

  • 00850011306253 ()
31-0604-0139

  • Medical networking interface unit
"UWIT-RX OLYMPUS WIRELESS RECEIVER"
OLYMPUS MEDICAL SYSTEMS CORP.
UWIT-RX
Not in Commercial Distribution

  • 04953170327711 ()


  • Medical networking interface unit
"UWIT-TX OLYMPUS WIRELESS TRANSMITTER"
OLYMPUS MEDICAL SYSTEMS CORP.
UWIT-TX
Not in Commercial Distribution

  • 04953170327681 ()


  • Medical networking interface unit
The Beacon transponder is a wireless device composed of an internal circuit and encapsulation materials. The internal circuit resonates in response to an external AC magnetic field. The resonance signal is used to measure the location of the transponders by the Calypso System. The Surface Beacon transponder is comprised of two Beacon transponders. The Surface Beacon transponder in its final packaged state is known as the Beacon Care Package - Surface.
VARIAN MEDICAL SYSTEMS, INC.
ASM0485-000
In Commercial Distribution

  • 00850011006016 ()
ASM0485-000

  • Real-time position management respiratory gating system, optical
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