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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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GammaPro Angled Standard Probe - B619GPROSTDANGPROBE0

GammaPro Angled Standard Probe used for wireless ionizing radiation detection.
Kubtec
K0021C01
In Commercial Distribution

  • B619GPROSTDANGPROBE0 ()


  • Mobile gamma camera system

GammaPro Laparoscopic Probe - B619GPROLAPPROBE0

GammaPro Laparoscopic Probe used for wireless ionizing radiation detection.
Kubtec
K0020C01
In Commercial Distribution

  • B619GPROLAPPROBE0 ()


  • Mobile gamma camera system

GammaPro Laparoscopic Probe with Tablet and Carry Case - B619GPROLAPKIT0

GammaPro Laparoscopic Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0020C02
In Commercial Distribution

  • B619GPROLAPKIT0 ()


  • Mobile gamma camera system

GammaPro High Sensitivity Probe - B619GPROHISPROBE0

GammaPro High Sensitivity Probe used for wireless ionizing radiation detection.
Kubtec
K0019C01
In Commercial Distribution

  • B619GPROHISPROBE0 ()


  • Mobile gamma camera system

GammaPro Hi-Sense Probe with Tablet and Carry Case - B619GPROHISKIT0

GammaPro Hi-Sense Probe with Tablet and Carry Case used for wireless ionizing radiation detection.
Kubtec
K0019C02
In Commercial Distribution

  • B619GPROHISKIT0 ()


  • Mobile gamma camera system

GammaPro Carry Case and Tablet - B619GPROCASETABL2

Table with installed software is used with wireless battery powered probes (different shapes and sizes) to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity.
Kubtec
K0017C01
In Commercial Distribution

  • B619GPROCASETABL2 ()


  • Mobile gamma camera system

Levo - G172616890

No Description
Levo Medical Corporation
Manager
In Commercial Distribution

61689

  • Tinnitus masking application software

Levo - G172604520

No Description
Levo Medical Corporation
Patient
In Commercial Distribution

60452

  • Tinnitus masking application software

MoMe® ARC - B690MA10

MoMe® ARC is a wireless, remote monitoring system designed to aid physicians in their diagnosis of cardiac arrhythmias in patients with a demonstrated need for cardiac monitoring. The MoMe® ARC device primarily consists of a Sensor, Gateway, and Charging dock with accessories. The body worn Sensor acquires, stores, and forwards ECG data to the Gateway using a 2.4GHz BLE wireless link; and the Gateway stores and forwards ECG signal data to the MoMe® Software Platform (K152491) over a 4G LTE cellular link. The Sensor and Gateway incorporate non-removable, rechargeable batteries, with the Gateway battery being wirelessly charged by the charging dock and the sensor battery being wirelessly charged by Gateway.
Infobionic, Inc.
30000
In Commercial Distribution

  • B690MA10 ()


  • Patient monitoring system module, electrocardiographic, telemetric

LEVO - B400215930

No Description
OTOHARMONICS CORPORATION
PATIENT
In Commercial Distribution

  • B400215930 ()


  • Tinnitus masking application software
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