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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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EchoPAC - 00195278951700

MD EchoPAC Software Only v210
GE Vingmed Ultrasound AS
Software Only v210
In Commercial Distribution

  • 00195278951700 ()


  • Ultrasound imaging system application software

Ion - 00886874116234

System Cart
INTUITIVE SURGICAL, INC.
380748
In Commercial Distribution

  • 00886874116234 ()


  • Surgical planning/navigation-enhancement system

HnX-PB - 08800070400166

The portable x-ray system may be used for diagnostic imaging of body extremities. - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
H&abyz Co., Ltd
HnX-PB
In Commercial Distribution

  • 08800070400166 ()


  • Portable basic diagnostic x-ray system, digital

HnX-P1 - 08800070400074

The portable x-ray system may be used for diagnostic imaging of body extremities. - Not for mammography use - This device is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
H&abyz Co., Ltd
HnX-P1
In Commercial Distribution

  • 08800070400074 ()


  • Portable basic diagnostic x-ray system, digital

OptiMap™ System - NA - 00850064686135

The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias.
Cortex, Inc.
FG0001-NA
In Commercial Distribution

  • 00850064686135 ()
OPTI-SYS-NA

  • Cardiac mapping system

OptiMap Monitor - 00850064686029

OptiMap Monitor
Cortex, Inc.
FG0009
In Commercial Distribution

  • 00850064686029 ()
OPTI-MON

  • Cardiac mapping system

OptiMap™ Workstation - 00850064686012

OptiMap Workstation
Cortex, Inc.
FG0008
In Commercial Distribution

  • 00850064686012 ()
OPTI-WS

  • Cardiac mapping system

Qube - 10841522131455

COMPACT MONITOR,91390
SPACELABS HEALTHCARE (WASHINGTON), INC
Qube Compact Monitor
In Commercial Distribution

  • 10841522131455 ()
91390

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230871

CIWS STD NEL SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230871 ()
  • 00732094119312 ()
84NXVX

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230826

CIWS WRLS NEL SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230826 ()
  • 00732094055054 ()
85NXVE

  • Multiple vital physiological parameter monitoring system, clinical

EnSite™ - 05415067053367

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-R-SYS-04
In Commercial Distribution

  • 05415067053367 ()
ENSITE-R-SYS-04

  • Cardiac mapping system

EnSite™ - 05415067053350

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-04
In Commercial Distribution

  • 05415067053350 ()
ENSITE-SYSTEM-04

  • Cardiac mapping system

EnSite™ - 05415067051257

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-04
In Commercial Distribution

  • 05415067051257 ()
ENSITE-DWS-04

  • Cardiac mapping system

EnSite™ - 05415067051226

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-04
In Commercial Distribution

  • 05415067051226 ()
ENSITE-R-DWS-04

  • Cardiac mapping system

Welch Allyn, Inc. - 00732094231014

CIWS WRLS MAS SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094231014 ()
  • 00732094118865 ()
85MXVX

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230901

CIWS STD MAS SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230901 ()
  • 00732094058086 ()
84MXVE

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230888

CIWS STD NEL SCS IRT
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230888 ()
  • 00732094057485 ()
84NXVE

  • Multiple vital physiological parameter monitoring system, clinical

Welch Allyn, Inc. - 00732094230857

CIWS WRLS NEL SCS
WELCH ALLYN, INC.
901028
In Commercial Distribution

  • 00732094230857 ()
  • 00732094118803 ()
85NXVX

  • Multiple vital physiological parameter monitoring system, clinical

PMT® CORPORATION HALO - 00650551044840

HEAD BLOCK ATTACH HARDWARE SET: (4) SOCKET HEAD CAP SCREWS, (4) WASHERS, (2) ALLEN WRENCHES
PMT CORPORATION
1201-36
In Commercial Distribution

  • 00650551044840 ()
1201-36

  • Cervical spine immobilization system, single-use

Axiom - 00840363369037

4 x 5 Lateral Pads, Curved with Adj. S/A Mounting Hardware for BTX Right
KI MOBILITY, LLC
Lateral Trunk Supports
In Commercial Distribution

  • 00840363369037 ()

  • Length: 4 Inch
  • Width: 5 Inch
PLLASC4x5BR

  • Wheelchair head/trunk support, prefabricated
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