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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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n/a - 07613327467208

Precision Targeting Guide
Stryker Leibinger GmbH & Co. KG
6000-802-000
In Commercial Distribution

  • 07613327467208 ()
6000-802-000

  • Surgical planning/navigation-enhancement 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

NA - 07613327298192

ADAPT Gamma3 DTS Clip
Stryker GmbH
1320-8201
In Commercial Distribution

  • 07613327298192 ()
1320-8201

  • Medical image management system

ADAPT - 07613327312430

PC Set
Stryker Leibinger GmbH & Co. KG
0101-2000
In Commercial Distribution

  • 07613327312430 ()
0101-2000

  • Medical image management system

ADAPT - 07613327312393

PC Unit
Stryker Leibinger GmbH & Co. KG
0101-2900
In Commercial Distribution

  • 07613327312393 ()
0101-2900

  • Medical image management system

NA - 07613327311822

ADAPT 2.0 for Gamma3 Software
Stryker GmbH
0101-0001
In Commercial Distribution

  • 07613327311822 ()
0101-0001

  • Medical image management system

Starling Monitor with SpO2 Module - 72900130302906

A portable, non-invasive cardiac output (CO) monitoring device with SpO2 module.
CHEETAH MEDICAL (ISRAEL) LTD
CMMST5S
Not in Commercial Distribution

  • 72900130302906 ()
CMMST5S

  • Multiple vital physiological parameter monitoring system, clinical

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
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