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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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Heron IOS system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Heron IOS system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
3D IMAGING AND SIMULATION CORP. AMERICAS
IOS-FP-71-001
In Commercial Distribution

  • 00864206000406 ()


  • Dental milling system, CAD/CAM, chairside
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
Disposable 3cc LL Syringe with Needle 23G x 1 1/2, Each
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
GE12041
In Commercial Distribution

  • 20864085000416 ()
  • 10864085000419 ()
  • 00864085000412 ()

  • Disposable 3cc LL Syringe with Needle 23G x 1 1/2, Each
GE12041

  • Hypodermic needle, single-use
  • General-purpose syringe, single-use
Disposable 10CC, LL Syringe, W/Needle, 21G x 1 1/2", Each,
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
GE12085
In Commercial Distribution

  • 20864085000409 ()
  • 10864085000402 ()
  • 00864085000405 ()

  • Disposable 10CC, LL Syringe, W/Needle, 21G x 1 1/2", Each,
GE12085

  • Hypodermic needle, single-use
  • General-purpose syringe, single-use
Saphenous Vein Cannula
COASTAL LIFE SYSTEMS, INC.
201006-000
In Commercial Distribution

  • 10864039000410 ()
  • 00864039000413 ()


  • Vascular irrigation cannula, cardiac vessel graft
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
Transmitter which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
BWI-D
In Commercial Distribution

  • 00864037000378 ()


  • 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 5.300
In Commercial Distribution

  • 00864037000354 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Windows 7 Tower which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
HTS820 Windows 7
In Commercial Distribution

  • 00864037000330 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Receiver which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
T-Link Receiver
In Commercial Distribution

  • 00864037000323 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Transmitter which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
TM8B Transmitter
In Commercial Distribution

  • 00864037000316 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Transmitter which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
TM8D Transmitter
In Commercial Distribution

  • 00864037000309 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
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