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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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Ambra Health Mobile Application - AMBRMOBILEAPP0

Mobile Application version of Ambra Health. Not intended for diagnostic purposes.
Ambra Health
AMBRMOBILEAPP0
In Commercial Distribution

  • AMBRMOBILEAPP0 ()


  • Radiology information system

Ambra PACS - AMBRHEALTHSOLUTIONS0

No Description
Ambra Health
3.16.10.0
In Commercial Distribution

  • AMBRHEALTHSOLUTIONS0 ()


  • Radiology information system

Ambra PACS - AMBRAPACS0

No Description
Ambra Health
3.24
In Commercial Distribution

  • AMBRAPACS0 ()


  • Radiology information system

THD Procto Software System - 68051887046715

THD DIGITAL MOBILE LIGHT is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform digital anoscopy, anorectal manometry and Transanal Ultrasound using dedicated hardwares. THD DIGITAL MOBILE LIGHT has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004).
THD SPA
THD DIGITAL MOBILE LIGHT
In Commercial Distribution

  • 68051887046715 ()
800320

  • Ultrasound imaging system application software

THD Procto Software System - 68051887043325

THD DIGITAL MOBILE ADVANCED is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry and Transanal Ultrasound. THD DIGITAL MOBILE ADVANCED has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes, THD Anopress (transportable anorectal manometer) for anorectal manometry and a Transanal Ultrasound Probe 12 MHz USB for laptop connection.
THD SPA
THD DIGITAL MOBILE ADVANCED
In Commercial Distribution

  • 68051887043325 ()
800309

  • Ultrasound imaging system application software

THD Procto Software System - 68051887043318

THD DIGITAL MOBILE ECOGRAPHY is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry (optional) and Transanal Ultrasound. THD DIGITAL MOBILE ECOGRAPHY has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes and a Transanal Ultrasound Probe 12 MHz USB for laptop connection.
THD SPA
THD DIGITAL MOBILE ECOGRAPHY
In Commercial Distribution

  • 68051887043318 ()
800308

  • Ultrasound imaging system application software

THD Procto Software System - 68051887043301

THD DIGITAL MOBILE MANOMETRY is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry. THD DIGITAL MOBILE MANOMETRY has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004), a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes and THD Anopress (transportable anorectal manometer) for anorectal manometry.
THD SPA
THD DIGITAL MOBILE MANOMETRY
In Commercial Distribution

  • 68051887043301 ()
800307

  • Ultrasound imaging system application software

THD Procto Software System - 68051887043295

THD DIGITAL MOBILE is an integrated mobile proctological platform for the Colo-Rectal Surgeon/ Proctologist which allows the proctologist to have a single, modular and expandable diagnostic system to perform anorectal manometry (optional) and Transanal Ultrasound (optional). THD DIGITAL MOBILE has a Laptop with Windows® operating system, pre-installed medical software for electronic capture, storage and reporting (THD Procto Software REF. 760004) and a HD VideoCamera connected via USB cable to Digital Mobile for outpatient diagnostics using our line of N-Ano diagnostic anoscopes.
THD SPA
THD DIGITAL MOBILE
In Commercial Distribution

  • 68051887043295 ()
800306

  • Ultrasound imaging system application software

THD Procto Software System - 58051887042642

THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions. Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound.
THD SPA
THD HRStation
In Commercial Distribution

  • 58051887042642 ()
800299

  • Ultrasound imaging system application software

CS WinOMS - 60889978014576

WinOMS Practice Management Software
CARESTREAM HEALTH, INC.
CS WinOMS
In Commercial Distribution

  • 60889978014576 ()
8014573

  • Physician-practice-management information system

Welch Allyn, Inc. - 00817655023281

CONTROL STORAGE POLISH 220V
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00817655023281 ()
SCNODE-CGB-AXBXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00817655023274

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Polish language and CD m anual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 0; Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment monitoring, and hemodynamic calculations (required for options with hard wired patient mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00817655023274 ()
SCSYS-IGD-ABFXX

  • Centralized patient monitor

Surveyor Central - 00817655023243

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-BAA-EMXEX
Not in Commercial Distribution

  • 00817655023243 ()


  • Centralized patient monitor

Surveyor Central - 00817655023236

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-CAA-CXBEX
Not in Commercial Distribution

  • 00817655023236 ()


  • Centralized patient monitor

Surveyor Central - 00817655023229

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-AAA-BJBEX
Not in Commercial Distribution

  • 00817655023229 ()


  • Centralized patient monitor

Welch Allyn, Inc. - 00817655023106

QTEL v5.0.1 eSIGNATURE SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00817655023106 ()
419734

  • Centralized patient monitor

Surveyor Central - 00817655023052

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCSYS-HAE-GHCCX
Not in Commercial Distribution

  • 00817655023052 ()


  • Centralized patient monitor

Surveyor Central - 00817655022949

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-AAA-EKBEX
Not in Commercial Distribution

  • 00817655022949 ()


  • Centralized patient monitor

Surveyor Central - 00817655022918

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCSYS-IAE-SDFAX
Not in Commercial Distribution

  • 00817655022918 ()


  • Centralized patient monitor

Surveyor Central - 00817655022901

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCNODE-AAA-AKDEX
Not in Commercial Distribution

  • 00817655022901 ()


  • Centralized patient monitor

Surveyor Central - 00817655022857

Patient Monitoring Central Station
MORTARA INSTRUMENT, INC.
SCSYS-HAE-RHFCA
Not in Commercial Distribution

  • 00817655022857 ()


  • Centralized patient monitor

ADVANCED PATIENT MONITOR - B510PMMAX15

No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-Max15
In Commercial Distribution

  • B510PMMAX15 ()


  • Multiple vital physiological parameter monitoring system, clinical

ADVANCED PATIENT MONITOR - B510PMMAX13

No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-Max13
In Commercial Distribution

  • B510PMMAX13 ()


  • Multiple vital physiological parameter monitoring system, clinical

ADVANCED PATIENT MONITOR - B510PM200MPRO1

No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-200M PRO
In Commercial Distribution

  • B510PM200MPRO1 ()


  • Multiple vital physiological parameter monitoring system, clinical

ADVANCED PATIENT MONITOR - B510PM2000XLPRO1

No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000XL PRO
In Commercial Distribution

  • B510PM2000XLPRO1 ()


  • Multiple vital physiological parameter monitoring system, clinical

ADVANCED PATIENT MONITOR - B510PM2000XLPLUS1

No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000XL PLUS
In Commercial Distribution

  • B510PM2000XLPLUS1 ()


  • Multiple vital physiological parameter monitoring system, clinical

ADVANCED PATIENT MONITOR - B510PM2000XL1

No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000XL
In Commercial Distribution

  • B510PM2000XL1 ()


  • Multiple vital physiological parameter monitoring system, clinical

ADVANCED PATIENT MONITOR - B510PM2000M1

No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000M
In Commercial Distribution

  • B510PM2000M1 ()


  • Multiple vital physiological parameter monitoring system, clinical

ADVANCED PATIENT MONITOR - B510PM2000APRO1

No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000A PRO
In Commercial Distribution

  • B510PM2000APRO1 ()


  • Multiple vital physiological parameter monitoring system, clinical

ADVANCED PATIENT MONITOR - B510PM2000A1

No Description
ADVANCED INSTRUMENTATIONS, INC.
PM-2000A
In Commercial Distribution

  • B510PM2000A1 ()


  • Multiple vital physiological parameter monitoring system, clinical

ADVANCED CENTRAL MONITORING STATION - B510CMS20001

No Description
ADVANCED INSTRUMENTATIONS, INC.
CMS-2000
In Commercial Distribution

  • B510CMS20001 ()


  • Centralized patient monitor

ADVANCED CENTRAL MONITORING STATION - B510CMS1000FM1

No Description
ADVANCED INSTRUMENTATIONS, INC.
CMS-1000FM
In Commercial Distribution

  • B510CMS1000FM1 ()


  • Centralized patient monitor

X-Guide - 00817421023361

X-Guide 3.7.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421023361 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022920

X-Guide 3.6.0 Linux Software (MDR)
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022920 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022838

X-Guide 3.6.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022838 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022821

X-Guide 3.5.8 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022821 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022814

X-Guide 3.5.4 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022814 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022791

EDX-S Tracker Arm, Vertical, Center
XNAV TECHNOLOGIES LLC
P011803
In Commercial Distribution

  • 00817421022791 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022784

X-Guide 3.5.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022784 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022753

X-Guide 3.5.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022753 ()


  • Surgical planning/navigation-enhancement system
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