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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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The electrode cable assembly connects to the Macroduct Advanced inducer at the electrode connector on the top panel. Both electrodes, one red for the anode (positive) and one black for the cathode (negative), have a stainless-steel disc as the electrode plate. In the center of each electrode is a pin for detecting the Pilogel disc. The electrodes provide current from the device through the Pilogel discs to the patient skin during iontophoresis.
ELITECHGROUP INC.
AC-203
In Commercial Distribution

  • 03661540300370 ()


  • Sweat-induction iontophoresis system
A dental diode laser system intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless footswitch and other accessories (power cord, protective eyewear, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400073 Replacement
In Commercial Distribution

  • 00647529004173 ()
7400073R

  • Dental diode laser system
A dental diode laser system intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless footswitch and other accessories (power cord, protective eyewear, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400073 Refurbished
In Commercial Distribution

  • 00647529002476 ()


  • Dental diode laser system
A dental diode laser system intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless footswitch and other accessories ( power cord, tip holder, protective eyewear). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400042 Refurbished
In Commercial Distribution

  • 00647529002452 ()


  • Dental diode laser system
A kit including a handpiece and tips intended to be utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
LaserFresh Accessory Kit Bundle
In Commercial Distribution

  • 00647529003787 ()
7220005

  • Dental solid-state laser system
A surgical and therapeutic device intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, tip holders, protective eyewear, screen protectors). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400073
In Commercial Distribution

  • 00647529000175 ()
7400073

  • Dental diode laser system
A surgical and therapeutic device intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless footswitch and other accessories (power cords, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7400042
In Commercial Distribution

  • 00647529000168 ()
7400042

  • Dental diode laser system
The AVACEN HOME+ consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME+ is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME+ for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
AVACEN HOME+
In Commercial Distribution

  • 00862800000358 ()


  • Electric pad localized-body heating system
The AVACEN HOME consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
AVACEN HOME
In Commercial Distribution

  • 00862800000303 ()


  • Electric pad localized-body heating system
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24 in. monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 w
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261073 ()
XSCRIBE-6AA-ADBXX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24 in. monitor with 1920 x 1080 resolution; UK power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261028 ()
XSCRIBE-6AA-CDBAB

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24 in. monitor with 1920 x 1080 resolution; UK power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261011 ()
XSCRIBE-6AA-CDBAC

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24 in. monitor with 1920 x 1080 resolution; UK power cord; No printer, basic laser transport cart with base and back panel; AHA 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Re
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094261004 ()
XSCRIBE-6AA-CEAAB

  • Electrocardiographic lead set, reusable
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24 in. monitor with 1920 x 1080 resolution; UK power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Re
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260991 ()
XSCRIBE-6AA-CEBAB

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer (includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; AHA 10 wire, 12-lead lead set with m
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260304 ()
XSCRIBE-6AD-ADAAB

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; US/Canada power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260298 ()
XSCRIBE-6AD-AEBAX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; Australia power cord; No printer, basic laser transport cart with base and back panel; AHA 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + XML Orde
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260274 ()
XSCRIBE-6AD-BEAAA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; UK power cord; Z200+ thermal printer (includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-cli
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260267 ()
XSCRIBE-6AD-CDBAB

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; UK power cord; Z200+ thermal printer (includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC 10 wire, 12-lead lead set with medi-cli
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260250 ()
XSCRIBE-6AD-CDBAC

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24 in. monitor with 1920 x 1080 resolution; International power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; AHA 10 wire, 12-lead lead set wit
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260243 ()
XSCRIBE-6AD-DDAAA

  • Cardiopulmonary stress exercise monitoring system computer
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