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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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Cognivue Advanced with Cart - 00860000564007

No Description
COGNIVUE, INC.
Cart Unit
In Commercial Distribution

  • 00860000564007 ()


  • Cognitive assessment software

IRRAflow Laser Leveler Package - 00868643000463

No Description
Irras USA, Inc.
ICLS 010
In Commercial Distribution

  • 10868643000460 ()
  • 00868643000463 ()
  • 20868643000467 ()
ICLS 010

  • Patient monitoring system module, intracranial pressure

INTELLISPACE™ COGNITION - 00884838108554

Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report.
Philips Electronics Nederland B.V.
6.0.x.x
In Commercial Distribution

  • 00884838108554 ()
821401000000

  • Cognitive assessment software

ScvO2 optical module - 06944904036700

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-008191-00
In Commercial Distribution

  • 06944904036700 ()


  • Patient monitoring system module, intracranial pressure

Signal set - 06430046260856

Signal product set including Signal Camera.
Optomed Oy
60101599A
In Commercial Distribution

  • 06430046260856 ()


  • Ophthalmic fundus camera

Signal Camera - 06430046260832

Ophthalmic fundus camera
Optomed Oy
41001595
In Commercial Distribution

  • 06430046260832 ()


  • Ophthalmic fundus camera

Visuscout 100 set FN - 06430046260634

Visuscout 100 set
Optomed Oy
60100054A
In Commercial Distribution

  • 06430046260634 ()


  • Ophthalmic fundus camera

EasyScan - 08719326032108

Scanning Laser Ophthalmoscope
EasyScan B.V.
EasyScan
In Commercial Distribution

  • 08719326032108 ()


  • Ophthalmic fundus camera

ESSILOR - 03664188000435

Automatic eye-fundus camera and software intended for photographing, displaying,and storing images of the retina without the use of a mydriatic agent.
LUNEAU TECHNOLOGY OPERATIONS
Retina 800
In Commercial Distribution

  • 03664188000435 ()
RET1IN

  • Ophthalmic fundus camera

Carl Zeiss Meditec - 03664188000428

No Description
LUNEAU TECHNOLOGY OPERATIONS
Velara 200
In Commercial Distribution

  • 03664188000428 ()


  • Ophthalmic fundus camera
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