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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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No Description
WAHTS HEARING LLC
0.X.X
In Commercial Distribution

  • 00860005068319 ()


  • Tone audiometer
No Description
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838000469 ()
860292

  • Electrocardiographic ambulatory recorder
Philips Holter Software w/ Zymed Alg
Philips Medical Systems Hsg
Philips Holter Software
In Commercial Distribution

  • 00884838094895 ()
860292

  • Electrocardiographic long-term ambulatory recording analyser application software
The NeXus software is intended to provide (near) real-time biofeedback and neurofeedback in the form of information, visual and auditory signals, corresponding to the state of one or more physiological parameters, so that a patient can learn voluntary control of these parameters. The software shall be used on a personal computer (in a medical office environment) in combination with compatible signal acquisition devices and sensor accessories to perform its intended use. The software is designed for medical use, not restricted to a specific medical indication. It is intended to be used within a medical office environment by, or under supervision of, a health professional (novice user, technical knowledge, normal eyesight, possibly achieved with the aid of glasses). The software is not intended for use in a life support application nor is it intended for diagnostic purposes.
Mind Media Europe B.V.
1.0.204.6
In Commercial Distribution

  • 08719481550332 ()


  • Biofeedback system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11149925
Not in Commercial Distribution

  • 04056869006833 ()


  • Radiological PACS software
No Description
ECENTIAL ROBOTICS
L00016
In Commercial Distribution

  • 03701311500445 ()


  • Robotic surgical navigation system application software
Actical Software Global
Respironics, Inc.
3.11
In Commercial Distribution

  • 00606959021013 ()
1081738

  • Kinesiology ambulatory recorder
Aurix software for use with the Aurix system (DI: 00627908080011) The UDI for software is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA002
Not in Commercial Distribution

  • 00627908090027 ()


  • Evoked-potential audiometer
Integrity software for use with the first generation Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version) UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA001
In Commercial Distribution

  • 00627908090010 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
No Description
Norland at Swissray
4
In Commercial Distribution

  • 00866955000478 ()


  • Basic diagnostic x-ray system operation software
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