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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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Sentinel - 10841522103452

Cardiology Information Management System
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103452 ()
10.0.1

  • Cardiac stress exercise monitoring system

PathfinderSL - 10841522103131

SENTINEL 10 WORKSTATION (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103131 ()
040-1713-00

  • Cardiology information system application software

SENTINEL - 10841522103124

SENTINEL 10 WORKSTATION (X10) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103124 ()
040-1712-00

  • Cardiology information system application software

Sentinel - 10841522103117

SENTINEL 10 WORKSTATION (X5) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103117 ()
040-1711-00

  • Cardiology information system application software

Sentinel - 10841522103100

SENTINEL 10 WORKSTATION (X2) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103100 ()
040-1710-00

  • Cardiology information system application software

Sentinel - 10841522103094

SENTINEL 10 WORKSTATION (X1) + ABP LICENSE
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522103094 ()
040-1709-00

  • Cardiology information system application software

SphygmoCor - 19351315000017

Packaged SphygmoCor CVMS systems including assembly module EM3 with UDI Direct Marking plus various components [SphygmoCor CVMS software CD, tonometer, power cord/adapter, ECG pads/leads/cables (CPV configuration only), footswitch, and others]. CONFIGURATIONS ENCOMPASSED BY THE CVMS VERSION/MODEL: • CvMS-CP Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only]. • CvMS-CPV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)] • CvMS-CPVH Configuration: [SphygmoCor software configured for pulse wave analysis (PWA), pulse wave velocity (PWV) and Heart Rate Variability (HRV)].
ATCOR MEDICAL PTY LTD
CVMS
In Commercial Distribution

  • 19351315000017 ()
  • 19351315000024 ()


  • Patient monitoring system module, multifunction

Endowrist SP - 00886874122228

CAMERA, 0°
INTUITIVE SURGICAL, INC.
430077
In Commercial Distribution

  • 00886874122228 ()

  • Outer Diameter: 6 Millimeter


  • Rigid optical laparoscope

Earlens Wireless Programmer - 00850013007110

Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
WPUSB01
Not in Commercial Distribution

  • 00850013007110 ()
WPUSB01

  • Hearing aid/implant system programming interface unit

Harmony - 00850003069593

Harmony 6.2 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
6.2
In Commercial Distribution

  • 00850003069593 ()


  • Camera application software

Harmony - 00850003069586

Harmony 6.1.1 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
6.1.1
In Commercial Distribution

  • 00850003069586 ()


  • Camera application software

Harmony - 00850003069579

Harmony 6.1 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
6.1
In Commercial Distribution

  • 00850003069579 ()


  • Camera application software

Harmony - 00850003069562

Harmony 5.09.004 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.09.004
In Commercial Distribution

  • 00850003069562 ()


  • Camera application software

Harmony - 00850003069555

Harmony 5.09.003 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.09.003
In Commercial Distribution

  • 00850003069555 ()


  • Camera application software

Harmony - 00850003069548

Harmony 5.09.002 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.09.002
In Commercial Distribution

  • 00850003069548 ()


  • Camera application software

Harmony - 00850003069531

Harmony 6.0 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
6.0
In Commercial Distribution

  • 00850003069531 ()


  • Camera application software

Harmony - 00850003069524

Harmony 5.09.001 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.09.001
In Commercial Distribution

  • 00850003069524 ()


  • Camera application software

Harmony - 00850003069517

Harmony 5.09 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.09
In Commercial Distribution

  • 00850003069517 ()


  • Camera application software

Harmony - 00850003069500

Harmony 5.08.001 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.08.001
In Commercial Distribution

  • 00850003069500 ()


  • Camera application software

Harmony - 00850003069432

Harmony 5.08 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.08
In Commercial Distribution

  • 00850003069432 ()


  • Camera application software

Harmony - 00850003069357

Harmony 5.07.004 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE INC
5.07.004
In Commercial Distribution

  • 00850003069357 ()


  • Camera application software

IMAGEnet 6 - 00850003069302

The IMAGEnet 6 ver. 2.4.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.
TOPCON HEALTHCARE SOLUTIONS, INC.
2.4.0
In Commercial Distribution

  • 00850003069302 ()


  • Camera application software

Harmony - 00850003069296

Harmony 5.06.003 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.06.003
In Commercial Distribution

  • 00850003069296 ()


  • Camera application software

Harmony - 00850003069289

Harmony 5.06.002 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.06.002
In Commercial Distribution

  • 00850003069289 ()


  • Camera application software

Harmony - 00850003069265

Harmony 5.07 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.07
In Commercial Distribution

  • 00850003069265 ()


  • Camera application software

IMAGEnet 6 - 00850003069241

The IMAGEnet 6 ver. 2.3.0 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.
TOPCON HEALTHCARE SOLUTIONS, INC.
2.3.0
In Commercial Distribution

  • 00850003069241 ()


  • Camera application software

Harmony - 00850003069234

Harmony 5.05.102 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.05.102
In Commercial Distribution

  • 00850003069234 ()


  • Camera application software

Harmony - 00850003069227

Harmony 5.05.101 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.05.101
In Commercial Distribution

  • 00850003069227 ()


  • Camera application software

IMAGEnet 6 - 00850003069203

The IMAGEnet 6 ver. 2.2.1 is a software program that is intended for use in the collection, storage and management of digital images, patient data and diagnostic data from Topcon devices.
TOPCON HEALTHCARE SOLUTIONS, INC.
2.2.1
In Commercial Distribution

  • 00850003069203 ()


  • Camera application software

Harmony - 00850003069197

Harmony 5.05.100 is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye.
TOPCON HEALTHCARE SOLUTIONS, INC.
5.05.100
In Commercial Distribution

  • 00850003069197 ()


  • Camera application software
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