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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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Vscan - 00195278884749

Vscan Air R3 for iOS
GE Vingmed Ultrasound AS
Air R3 for iOS
In Commercial Distribution

  • 00195278884749 ()


  • Ultrasound imaging system application software

Digital Expert Access - 00195278707741

DE MR Remote Scan Modality Connectivity Executable_1.5.6-RS
GE HEALTHCARE
with Remote scanning for MR
In Commercial Distribution

  • 00195278707741 ()
5941611

  • MRI system application software

Vscan - 00195278640574

Vscan Air R2 Upgrade kit
GE Vingmed Ultrasound AS
Air R2 CL
In Commercial Distribution

  • 00195278640574 ()


  • Ultrasound imaging system application software

Vscan - 00195278640567

Vscan Air R2 for Android
GE Vingmed Ultrasound AS
Air R2 for Android
In Commercial Distribution

  • 00195278640567 ()


  • Ultrasound imaging system application software

Vscan - 00195278640550

Vscan Air R2 for iOS
GE Vingmed Ultrasound AS
Air R2 for iOS
In Commercial Distribution

  • 00195278640550 ()


  • Ultrasound imaging system application software

Vscan - 00195278884725

Vscan Air R3 for Android
GE Vingmed Ultrasound AS
Air R3 for Android
In Commercial Distribution

  • 00195278884725 ()


  • Ultrasound imaging system application software

Venue Sprint - 00195278754011

Venue Sprint R5 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R5
In Commercial Distribution

  • 00195278754011 ()


  • Ultrasound imaging system application software

NA - 04055207057537

DRIVER HF UNIT KLS MARTIN
Richard Wolf GmbH
5592606
Not in Commercial Distribution

  • 04055207057537 ()
5592606

  • Operating room audiovisual data/device management system application software

NA - 04055207070086

CHECKLIST APP This app requires core.portal. The checklist app is a universal questionnaire and checklist system for collecting information during surgery. Checklists can be defined as customer-specific multilingual templates. The checklists are displayed in accordance with the language selected in the core.browser. The app generates a PDF report with the demographic patient data, information about the surgical intervention, a logo and the recorded data. The report is part of the documentation. The app does not spread the information collected.
Richard Wolf GmbH
5597706
Not in Commercial Distribution

  • 04055207070086 ()
5597706

  • Operating room audiovisual data/device management system application software

NA - 04055207070079

MEDIA ARCHIVE FILESHARE This module requires core.portal. It allows the storage of intraoperative data to an enabled directory in the hospital’s IT infrastructure. The module is required once for each file sharing approval.
Richard Wolf GmbH
5597203
Not in Commercial Distribution

  • 04055207070079 ()
5597203

  • Operating room audiovisual data/device management system application software
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