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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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Clinician Programmer
AXONICS MODULATION TECHNOLOGIES, INC.
2501
In Commercial Distribution

  • 10810005340035 ()
2501

  • Implantable incontinence-control electrical stimulation system programmer, line-powered
Clinician Programmer
AXONICS MODULATION TECHNOLOGIES, INC.
1501
In Commercial Distribution

  • 10810005340028 ()
1501

  • Implantable incontinence-control electrical stimulation system programmer, line-powered
No Description
BIOTRONIK SE & Co. KG
435292
In Commercial Distribution

  • 04035479158330 ()
435292

  • Implantable cardiac monitor programmer/transmitter/alarm
No Description
BIOTRONIK SE & Co. KG
Remote Assistant
Not in Commercial Distribution

  • 04035479144227 ()
405475

  • Implantable cardiac monitor programmer/transmitter/alarm
Gating Module for Probeam
DYN'R
1.0
Not in Commercial Distribution

  • 03615070000903 ()
SDX0365V1.0

  • Real-time position management respiratory gating system, optical
Gating Module for Siemens 4D-CT
DYN'R
1.0
Not in Commercial Distribution

  • 03615070000408 ()
SDX0361V1.0

  • Real-time position management respiratory gating system, optical
Orthex P&C Software v2
ORTHOPEDIATRICS CORP.
ORTHEXSW
In Commercial Distribution

  • 00840194428002 ()
ORTHEXSW

  • External orthopaedic fixation frame calculation software
No Description
NEUROLOGICA CORP.
10-01148-001
In Commercial Distribution

  • 10815411020274 ()


  • General-purpose diagnostic x-ray phantom, test object
The Riester camera system (RCS-100) is a portable and multifunctional electronic imaging diagnostic system which consists of OT, DE, and GE three replaceable modules. This camera system is designed to be operated by anyone who is eighteen years and older or medical professionals to capture images and video in specified operating environment.
Rudolf Riester GmbH
1970-HDGO
In Commercial Distribution

  • 04045396211186 ()
1970-HDGO

  • Multi-purpose digital medical camera
The Riester camera system (RCS-100) is a portable and multifunctional electronic imaging diagnostic system which consists of OT, DE, and GE three replaceable modules. This camera system is designed to be operated by anyone who is eighteen years and older or medical professionals to capture images and video in specified operating environment.
Rudolf Riester GmbH
1970-H
In Commercial Distribution

  • 04045396211063 ()
1970-H

  • Multi-purpose digital medical camera
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