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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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ANNE Bedside Wireless Charger - 00850064210057

Bedside charger for the ANNE Chest and ANNE Limb sensors.
Sibel Health Inc.
900-00008
In Commercial Distribution

  • 00850064210057 ()


  • Wearable multiple vital physiological parameter monitor

1-Day ANNE Chest Adhesive Pouch - 00850064210026

Pouch of 10 1-Day adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00014
In Commercial Distribution

  • 00850064210026 ()


  • Wearable multiple vital physiological parameter monitor

7-Day ANNE Chest Adhesive Pouch - 00850064210019

Pouch of 5 7-Day Adhesives for the ANNE Chest sensor.
Sibel Health Inc.
900-00038
In Commercial Distribution

  • 00850064210019 ()


  • Wearable multiple vital physiological parameter monitor

ANNE Chest Sensor Kit - 00850064210002

The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature.
Sibel Health Inc.
900-00007
In Commercial Distribution

  • 00850064210002 ()


  • Wearable multiple vital physiological parameter monitor

Harmony Referral System - 06430078740265

No Description
Topcon Healthcare Solutions EMEA Oy
3.9.1
In Commercial Distribution

  • 06430078740265 ()


  • Medical image management system

Harmony Referral System - 06430078740005

Harmony is a web-based software solution that connects all examination instruments, eye care professionals, and the latest technologies to ensure the best possible patient care and customer experience.
Topcon Healthcare Solutions EMEA Oy
3.8.1
In Commercial Distribution

  • 06430078740005 ()


  • Medical image management system

Bone Drill - 14719878713112

No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
MSI-PDL-01
In Commercial Distribution

  • 14719878713112 ()


  • Surgical planning/navigation-enhancement system

Minimally Invasive Spine Surgery Instruments - 14719878713099

No Description
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
MSI-02
In Commercial Distribution

  • 14719878713099 ()


  • Surgical planning/navigation-enhancement system

SIUI - 06938396423025

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300S
In Commercial Distribution

  • 06938396423025 ()


  • Portable basic diagnostic x-ray system, digital

SIUI - 06938396423018

Portable DR Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd.
SR-2300
In Commercial Distribution

  • 06938396423018 ()


  • Portable basic diagnostic x-ray system, digital
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