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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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ZR7, KIT 312 NFM 90 L BE ZERENA 7
Bernafon AG
186031
In Commercial Distribution

  • 05711584084335 ()


  • Air-conduction hearing aid, in-the-ear
ZR7, KIT 312 NFM 85 PB T L BE ZERENA 7
Bernafon AG
186029
In Commercial Distribution

  • 05711584084311 ()


  • Air-conduction hearing aid, in-the-ear
ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
2
In Commercial Distribution

  • 00864127000356 ()


  • Cognitive assessment software
ZR7, KIT 312 NFM 85 PB L BE ZERENA 7
Bernafon AG
186027
In Commercial Distribution

  • 05711584084298 ()


  • Air-conduction hearing aid, in-the-ear
No Description
IMPACT APPLICATIONS, INC.
1
In Commercial Distribution

  • 00864127000332 ()


  • Cognitive assessment software
ZR7, KIT 312 NFM 85 L BE ZERENA 7
Bernafon AG
186025
In Commercial Distribution

  • 05711584084274 ()


  • Air-conduction hearing aid, in-the-ear
ZR7, KIT 312 NFM 75 R BE ZERENA 7
Bernafon AG
186022
In Commercial Distribution

  • 05711584084243 ()


  • Air-conduction hearing aid, in-the-ear
ZR7, KIT 312 2.4G NFM R BE ZERENA 7
Bernafon AG
186016
In Commercial Distribution

  • 05711584084182 ()


  • Air-conduction hearing aid, in-the-ear
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter 5.400
In Commercial Distribution

  • 00864037000392 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Software which displays a patient's vital signs as part of the HTS820 patient-monitoring system.
LIFE SENSING INSTRUMENTS, INC.
TrensCenter VSP 1.000
In Commercial Distribution

  • 00864037000385 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
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