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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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Surveyor Repeater Node with no Hardware Italian language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901140
Not in Commercial Distribution

  • 00732094325362 ()
SCREP-DEB-XXXXX

  • Centralized patient monitor
Procellera Power Pack, 4" Diameter, & Energel
Vomaris Wound Care, Inc.
4"Diam CD & Energel
In Commercial Distribution

  • 00810198030259 ()
VHK-D04-05

  • Bioelectric wound dressing
Procellera Power Pack, 4"x4" Composite, & Energel
Vomaris Wound Care, Inc.
4"x4" CD & Energel
In Commercial Distribution

  • 00810198030266 ()
VHK-0404-05

  • Bioelectric wound dressing
The NIDEK US-500 Echoscan is an ultrasonic device to measure the axial length and corneal thickness and provide the information to be used for diagnosis. Axial length is one of the parameters used to determine the refractive power of an IOL prior to cataract surgery. By inputting the measured axial length with other parameters, the refractive power of an IOL can be calculated. Corneal thickness is a necessary parameter when considering the clinical influence of surgery, drugs and contact lenses upon endothelium tissue. Pachymetry is now commonly performed prior to and after corneal refractive surgery using devices such as the excimer laser. The US-500 is comprised of a touch screen, main body with a built-in printer, Pachymetry probe, and foot switch.
NIDEK CO.,LTD.
US-500
In Commercial Distribution

  • 04987669100455 ()


  • Ophthalmic ultrasound imaging system
  • Ultrasound pachymeter
Ultrasonic waves are the sound waves pitched above the range of human hearing whose frequency is 20,000 Hz or more. In the medical field, ultrasonic waves of frequencies between 1 and 15 MHz are applied, and these types of high sound waves have the following characteristics similar to light: They have a high tendency to travel in a straight direction. They have characteristics such as reflect.
NIDEK CO.,LTD.
US-4000
In Commercial Distribution

  • 04987669100448 ()


  • Ultrasound pachymeter
  • Ophthalmic ultrasound imaging system
The DGH1500-50 is a 50 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.
DGH TECHNOLOGY INC.
DGH1500-50
In Commercial Distribution

  • 00857377006162 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The DGH1500-35 is a 35 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.
DGH TECHNOLOGY INC.
DGH1500-35
In Commercial Distribution

  • 00857377006155 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The DGH1500 is a single-element mechanical sector UBM probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software.
DGH TECHNOLOGY INC.
DGH1500
In Commercial Distribution

  • 00857377006148 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The DGH1912 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software.
DGH TECHNOLOGY INC.
DGH1912
In Commercial Distribution

  • 00857377006131 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The DGH1920 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software.
DGH TECHNOLOGY INC.
DGH1920
In Commercial Distribution

  • 00857377006124 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The system consists of three main components: an interface module with integrated probe holder, one or more ultrasonic probes, and the Scanmate software application.
DGH TECHNOLOGY INC.
Scanmate Flex
In Commercial Distribution

  • 00857377006117 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The DGH 8000 uses ultrasonic pulse technology to create 2-dimensional, cross-section images of the human eye.
DGH TECHNOLOGY INC.
DGH 8000
In Commercial Distribution

  • 00857377006100 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
No Description
ACCUTOME, INC.
24-8000
In Commercial Distribution

  • 00897826002079 ()
24-8000

  • Ultrasound pachymeter
  • Ophthalmic ultrasound imaging system
MD-1000A/P Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters and corneal thickness.
Meda Co., Ltd
MD-1000A/P
In Commercial Distribution

  • 06948941111123 ()


  • Ultrasound pachymeter
  • Ophthalmic ultrasound imaging system
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; Australia power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094257779 ()
HSCRIBE-6AC-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; US power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264104 ()
HSCRIBE-6AC-AXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; UK power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264067 ()
HSCRIBE-6AC-CXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; International\Canada power cord; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264029 ()
HSCRIBE-6AC-DXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; No Acquisition Module; Software kit; Australia power cord; No printer, no transport cart; No lead set; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094263183 ()
QS-6XC-BXXXX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe/RScribe Server - version 6, current software CD; Software kit; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094257748 ()
XSERV-6AA-XXXXA

  • 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; No power cord; No printer, no transport cart; No lead set; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259476 ()
XSCRIBE-6CC-XXXXX

  • Cardiopulmonary stress exercise monitoring system computer
HScribe Review Workstation - version 6 for HScribe review, edit, and signing capabilities. Includes current software CD and user manual CD; Turnkey workstation with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094301564 ()
HSCRIBWS-6AA-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software activation only; No power cord, activation only; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094286137 ()
HSCRIBE-6AD-ZXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; Australia power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264098 ()
HSCRIBE-6AC-BXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; UK power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264074 ()
HSCRIBE-6AC-CXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software
TIMS System connects to all analog and digital modalities. Usage includes video and image acquisition, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS OEM Rev L
Not in Commercial Distribution

  • 00850951007272 ()
061000-OEM-CPU-HD+C

  • Radiology picture archiving and communication system workstation
TIMS System connects to all analog and digital modalities. Usage includes video and image acquisition, CD/DVD/USB burning.
FORESIGHT IMAGING, LLC
TIMS OEM Rev K
Not in Commercial Distribution

  • 00850951007104 ()
061000-OEM-CPU-HD+C

  • Radiology picture archiving and communication system workstation
Kit Contains: 3 each GO2VENT Model 6123; 1 each Oxygen Regulator; 1 each Training CD; 1 each Test Lung
VORTRAN MEDICAL TECHNOLOGY 1, INC
PCK-5050
In Commercial Distribution

  • 20637320050503 ()
PCK-5050

  • Pulmonary resuscitator, pneumatic, single-use
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; No Acquisition Module; Software kit; No power cord; No printer, no transport cart; No lead set; No isolation transformer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259032 ()
XSCRIBE-6XC-XXXXB

  • Cardiopulmonary stress exercise monitoring system computer
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; UK power cord; No printer; Server interface (remote database requires HScribe Server)
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094338812 ()
HSCRIBE-6AC-CXXXC

  • Electrocardiographic long-term ambulatory recording analyser application software
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