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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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WVSM Wireless Vital Signs Monitor - B3945000001010

Wireless Patient Monitor
ATHENA GTX, INC.
WVSM 5.0
In Commercial Distribution

  • B3945000001010 ()
500-0001-01

  • Multiple-patient intensive/general healthcare physiologic monitoring system
  • Multiple vital physiological parameter monitoring system, clinical

Penumbra Coil 400 - 00815948025103

Coil 400 Standard, 15mm x 45cm
PENUMBRA, INC.
4002C1545-A
In Commercial Distribution

  • 00815948025103 ()
4002C1545

  • Neurovascular embolization coil
  • Surgical microscope video camera, sterilizable

Bioness Integrated Therapy System, BITS 3.0, BITS Balance - 00815962020610

Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS Software Kit, BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
BIONESS INC.
BITS-3055
In Commercial Distribution

  • 00815962020610 ()


  • Perceptual-coordination assistive training device

ACIST HDi® HD IVUS System - 40841716102057

HDi System Overpack, with ACIST Connect, JAPAN p/n 801081-001 Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply, ACI Hardware
ACIST MEDICAL SYSTEMS, INC.
016323
Not in Commercial Distribution

  • 40841716102057 ()


  • Cardiovascular ultrasound imaging system

Welch Allyn, Inc. - 00732094264999

E-Scribe ECG Data Management Workstation - Rx system, floating; English system language; 220V power; Tower workstation computer hardware (no keyboard, mouse, or display); 19 in. display monitor
WELCH ALLYN, INC.
901134
In Commercial Distribution

  • 00732094264999 ()
ESWKST-FAB-AAXXX

  • Patient health record information system application software

VISIUSmatrix - 00857534006363

Application Platform 2.4 NA
IMRIS Imaging, Inc.
115407-000
In Commercial Distribution

  • 00857534006363 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006684

Applications Platform 4.0 INTL – INT KIT – 3 Room
IMRIS Imaging, Inc.
120088-000
In Commercial Distribution

  • 00857534006684 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006677

Applications Platform 4.0 INTL – INT KIT
IMRIS Imaging, Inc.
120086-000
In Commercial Distribution

  • 00857534006677 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006660

Applications Platform 4.0 INTL – 3 Room
IMRIS Imaging, Inc.
119898-000
In Commercial Distribution

  • 00857534006660 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system

VISIUSmatrix - 00857534006653

Applications Platform 4.0-INTL-2-Room
IMRIS Imaging, Inc.
119408-000
In Commercial Distribution

  • 00857534006653 ()


  • Operating room audiovisual data/device management system application software
  • Operating room audiovisual data/device management system
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