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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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qube - 10841522100550

COMPACT MONITOR,91390
SPACELABS HEALTHCARE (WASHINGTON), INC
91390
Not in Commercial Distribution

  • 10841522100550 ()
91390

  • Multiple vital physiological parameter monitoring system, clinical

Xhibit - 10841522100536

DISPLAY,22" CAPACITIVE TOUCH,BLACK,ANTI-GLARE
SPACELABS HEALTHCARE (WASHINGTON), INC
Exhibit Central
In Commercial Distribution

  • 10841522100536 ()
011-0241-01

  • Centralized patient monitor

Xhibit - 10841522100345

XHIBIT CENTRAL STATION,96102
SPACELABS HEALTHCARE (WASHINGTON), INC
96102
Not in Commercial Distribution

  • 10841522100345 ()
96102

  • Centralized patient monitor

qube mini - 10841522100239

QUBE MINI TRANSPORT MONITOR
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Mini
Not in Commercial Distribution

  • 10841522100239 ()
91389

  • Multiple vital physiological parameter monitoring system, clinical

Spacelabs Healthcare - 10841522100222

Remote Display Controller
SPACELABS HEALTHCARE (WASHINGTON), INC
91388
In Commercial Distribution

  • 10841522100222 ()
N/A

  • Centralized patient monitor

UltraviewSL - 10841522108716

MONITOR, COMPACT, REFURBISHED
SPACELABS HEALTHCARE (WASHINGTON), INC
91369
In Commercial Distribution

  • 10841522108716 ()
R-91369

  • Multiple vital physiological parameter monitoring system, clinical

Augmented Reality Application - G67910

No Description
Sira Medical, Inc.
1
In Commercial Distribution

  • G67910 ()


  • Surgical planning/navigation-enhancement system

CLAROX plus - 08800124900017

VX-100 is a battery-operated, portable X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-ray images. The VX-100 is designed for use in general-purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Because of its low power output, the CLAROX plus (Model VX-100) is intended for exclusive use on body extremities. The functions of the VX-100 handheld system are supported by software (firmware).
VSI Co., Ltd.
VX-100
In Commercial Distribution

  • 18800124900014 ()
  • 08800124900017 ()


  • Portable basic diagnostic x-ray system, digital

OPAL HDx™ - 00191506055370

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004OPLINSTALL2EN0
In Commercial Distribution

  • 00191506055370 ()
M004OPLINSTALL2EN0

  • Cardiac mapping system

OPAL HDx™ - 00191506055325

Mapping System Signal Station
BOSTON SCIENTIFIC CORPORATION
M004OPAL10200
In Commercial Distribution

  • 00191506055325 ()
M004OPAL10200

  • Cardiac mapping system
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