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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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, no display; 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; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260854 ()
XSCRIBE-6AB-CEBAX

  • 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; Software kit; International 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; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260519 ()
XSCRIBE-6AC-DEBAB

  • 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; Software kit; International 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; Server interface (remote database requires XScribe Server)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260502 ()
XSCRIBE-6AC-DEBAC

  • 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; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260489 ()
XSCRIBE-6AC-DEBXA

  • 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; Software kit; No 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; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260342 ()
XSCRIBE-6AC-XEBAB

  • 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; Turnkey system with configured CPU, no display; International 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; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259896 ()
XSCRIBE-6CB-DEBAA

  • 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; Software kit; 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-clips; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259810 ()
XSCRIBE-6CC-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; Software kit; 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-clips; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259797 ()
XSCRIBE-6CC-CDBAX

  • 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; Software kit; 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 with medi-clips; Isolation transformer 1000 VA Med Global; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259704 ()
XSCRIBE-6CC-DDAAX

  • 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 and RScribe with Interpretation; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259285 ()
XSCRIBE-6EC-DEBXB

  • 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 and RScribe with Interpretation; Software kit; International 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; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259186 ()
XSCRIBE-6GC-DEBAA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module and RScribe with Interpretation; Turnkey system with configured CPU, no display; International 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; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259070 ()
XSCRIBE-6HB-DEBAB

  • 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; Software kit; 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; Server interface (remote database requires XScribe Server)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260724 ()
XSCRIBE-6AC-BEAAC

  • 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; Software kit; 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; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260649 ()
XSCRIBE-6AC-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; Software kit; 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; IEC 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259681 ()
XSCRIBE-6CC-DDBAB

  • Cardiopulmonary stress exercise monitoring system computer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including mounting bracket for Connex Spot Monitor Device (order CSM device separately), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Vital Signs Accessory Basket, Vital Signs Monitor Power Supply (7000-PS), Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094230604 ()
77794-2MCSM

  • Aneroid manual sphygmomanometer
ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile. ClearON Mobile receives digital images from a flat panel detector and a X-ray generator. The software also manages patient data, stores and transfers diagnostic images in an internal database.  It supports DICOM image file format which allows interoperability with other Radiography equipment in network environment.  
Rayence Co., Ltd.
ClearON Mobile
In Commercial Distribution

  • 08800018600573 ()


  • Basic diagnostic x-ray system application software
The OXYLIGHT IONIX System is a multi-modality skin surface treatment system that uses multiple therapeutic modalities delivered through different attachments or handles connected to a main body. The system includes an LED panel/ lamp that irradiates Blue, Red and Yellow LED light and a Negative ION Mist. The system also includes various handles that deliver a variety of therapeutic modalities including microdermabrasion, LED light and Oxygen spray.
RAJA Medical
OXYLIGHT IONIX
In Commercial Distribution

  • G050OXYLIGHTIONIX0 ()
OXYLIGHT IONIX

  • Multi-modality skin surface treatment system
The IONIXLIGHT System is a multi-modality skin surface treatment system that uses multiple therapeutic modalities delivered through different attachments or handles connected to a main body. The system includes an LED panel/ lamp that irradiates Blue, Red and Yellow LED light and a Negative ION Mist. The system also includes various handles that deliver a variety of therapeutic modalities including microdermabrasion, LED light and Oxygen spray.
RAJA Medical
IONIXLIGHT
In Commercial Distribution

  • G050IONIXLIGHT0 ()
IONIXLIGHT

  • Multi-modality skin surface treatment system
The NIDEK REFRACTOR Model RT-3100 is a computerized refractor used for subjective refraction with the NIDEK AUTO REFRACTOMETER (AR), AUTO REF/KERATOMETER (ARK), AUTO REF/ KER/TONOMETER (RKT), or AUTO LENSMETER (LM) via Eye Care card. The RT-3100 includes a refractor head, control box, and relay box. The relay box not only connects the other two units, but also connects the Chart Presenting device or PC. The control box includes the key panel, display, and printer. The display is a touch-screen panel. The control box displays the data and can be used for almost all operations. In addition, the control box operates the refractor head and the connected chart presenting device. It allows the refractor and charts to be controlled together. Normally, the relay box is installed on the system table (not included in the RT-3100 package.)
NIDEK CO.,LTD.
RT-3100
In Commercial Distribution

  • 04987669100813 ()


  • Phoropter
The SpectraWAVE Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system. The SpectraWAVE Imaging System consists of the following components: • Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface. • Software: A proprietary application software that orchestrates the control, acquisition, processing, and display of the OCT-NIRS data. • Controller: A tethered controller that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console. • Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.
Spectrawave, Inc.
931
In Commercial Distribution

  • 00860008045515 ()
931

  • Coronary optical coherence tomography system
  • Intravascular near-infrared spectroscopy imaging system
The SpectraWAVE Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system. The SpectraWAVE Imaging System consists of the following components: • Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface. • Software: A proprietary application software that orchestrates the control, acquisition, processing, and display of the OCT-NIRS data. • Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console. • Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.
Spectrawave, Inc.
951
In Commercial Distribution

  • 00860008045508 ()
951

  • Intravascular near-infrared spectroscopy imaging system catheter
  • Coronary optical coherence tomography system catheter
Reliefband® Premier Slate Blue is a rechargeable, digital wearable device that is worn on the wrist. It consists of a hypoallergenic band with a control panel on top and two electrical contacts underneath. The two contacts must be placed firmly against the underside of your wrist at the P6 location. A fully charged battery will last for approximately 18 hours of continuous use at the mid-power level or below.
RELIEFBAND TECHNOLOGIES LLC
2.0 Slate Blue
In Commercial Distribution

  • 30661168600030 ()
  • 00661168600039 ()
  • 50661168600034 ()
2.0

  • Anti-nausea transcutaneous electrical nerve stimulation wristband
Reliefband® Premier Charcoal is a rechargeable, digital wearable device that is worn on the wrist. It consists of a hypoallergenic band with a control panel on top and two electrical contacts underneath. The two contacts must be placed firmly against the underside of your wrist at the P6 location. A fully charged battery will last for approximately 18 hours of continuous use at the mid-power level or below.
RELIEFBAND TECHNOLOGIES LLC
2.0 Charcoal
In Commercial Distribution

  • 30661168600023 ()
  • 00661168600022 ()
  • 50661168600027 ()
2.0

  • Anti-nausea transcutaneous electrical nerve stimulation wristband
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, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7200854-09
In Commercial Distribution

  • 00647529000076 ()
7200854-09

  • Dental solid-state laser system
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, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, platinum, premier
In Commercial Distribution

  • 00647529004401 ()
7200854-209

  • Dental solid-state laser system
A handpiece for a dental 980nm diode laser system intended for a variety of soft-tissue procedures. The dental diode laser 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 foot-switch and other accessories (power cord, protective eyewear, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
Handpiece, 1pk
In Commercial Distribution

  • 00647529004159 ()
7420006

  • Dental diode laser system
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, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, platinum, w/ C&V indication
In Commercial Distribution

  • 00647529003893 ()
7200854-09

  • Dental solid-state laser system
A handpiece 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.
Fractional Handpiece Kit
In Commercial Distribution

  • 00647529003770 ()
  • 00647529003756 ()
7220002

  • Dental solid-state laser system
A handpiece 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.
Fractional Handpiece Kit
In Commercial Distribution

  • 00647529003633 ()
7220002

  • Dental solid-state laser system
A laser system intended for a variety of surgical and oral soft-tissue procedures and dental tooth whitening. 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, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
Dental soft tissue diode laser system refurbished
In Commercial Distribution

  • 00647529003473 ()
7410001P

  • Dental diode laser system
A laser system intended for a variety of surgical and oral soft-tissue procedures and dental tooth whitening. 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, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7410001
In Commercial Distribution

  • 00647529002605 ()
7410001

  • Dental diode laser system
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 holders, tip cleaning kits). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7200854-05 Refurbished
In Commercial Distribution

  • 00647529002384 ()


  • Dental solid-state laser system
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, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7200854-03 Refurbished
In Commercial Distribution

  • 00647529002360 ()


  • Dental solid-state laser 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; Software kit; No power cord; Z200+ thermal printer (includes starter pack of full-grid paper - 8"), XScribe basic transport cart with base, back panel, and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094308433 ()
XSCRIBE-6AC-XCAXX

  • 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; Software kit; International 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; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260526 ()
XSCRIBE-6AC-DEBAA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU, no display; International 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 + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260151 ()
XSCRIBE-6BB-DEAAB

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU, no display; International 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; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260137 ()
XSCRIBE-6BB-DEBAB

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; International 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; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260076 ()
XSCRIBE-6BC-DEBAA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; No 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; Server interface (remote database requires XScribe Server)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260038 ()
XSCRIBE-6BC-XEBAC

  • Cardiopulmonary stress exercise monitoring system computer
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