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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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No Description
Virtual Vision Health
2.6.0
In Commercial Distribution

  • 00860010709733 ()


  • Perimeter, automatic
D-Scope Systems server software enables data and media synchronization features within the client's medical facilities by integrating with the client information system and patient EMR (HL7) and PACS/VNA (DICOM).
D-Scope Systems
6
In Commercial Distribution

  • 00860009377615 ()


  • Endoscopic video image processing unit
D-Scope Systems workstation software is a hardware-agnostic application for HD-quality medical video and image recording in clinical and OR settings. The user interface allows capture, marking, storage and sharing of files that has integration capability with patient EMR (HL7) and PACS/VNA (DICOM). The application and its browser allow access to a secure space within the client's network that facilitates remote and local file review, referrals and consultations with a HIPAA conformant logon authorization. Intended functions include medical process automation: procedural steps, population of patient demographic data, and management of active medical media from scheduling through discharge.
D-Scope Systems
6
In Commercial Distribution

  • 00860009377608 ()


  • Endoscopic video image processing unit
B125/B105 V1.5 SW PACK (USB) - MD
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V1.5
Not in Commercial Distribution

  • 00840682141291 ()


  • General-purpose multi-parameter bedside monitor
No Description
Gynesonics, Inc.
SW-002
In Commercial Distribution

  • 10817929020340 ()
SW-002

  • Ultrasound-guided radio-frequency ablation system software
No Description
RENISHAW MAYFIELD
neuroinspire SW Atlas Module
In Commercial Distribution

  • 03662724000482 ()
001.0123

  • Neurological stereotactic surgery system
No Description
RENISHAW MAYFIELD
neuroinspire planning software
In Commercial Distribution

  • 03662724000390 ()
001.0142

  • Neurological stereotactic surgery system
No Description
FOURNITURES HOSPITALIERES INDUSTRIE
0100011575
In Commercial Distribution

  • 03661489709067 ()


  • Orthopaedic/craniofacial implantation planning software
Holter Analysis Enhanced Plus
Northeast Monitoring, Inc.
Enhanced Plus
In Commercial Distribution

  • M581NEMK1620 ()
NEMK162

  • Cardiac arrhythmia monitoring system
The SYNCT Software is a desktop application that can be utilized by an end-user on a standalone computer, providing users the ability to operate general functions such as Order Management, with or without a Laboratory Information System (LIS), viewing test results, reviewing and preparing test reports, performing software administrative functions, and providing security control for permitted functions.
LUMINEX CORPORATION
CN-SW47
In Commercial Distribution

  • 00840487100448 ()


  • Laboratory instrument/analyser application software IVD
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