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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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IH-Com V5.0 - 07611969234417

IH-Com V5.0, Software Version 5.0.10
Bio-Rad Medical Diagnostics GmbH
5.0.10
In Commercial Distribution

  • 07611969234417 ()
009101

  • Laboratory instrument/analyser application software IVD

Oxevision Sleep system - 50607514500023

Sleep disorder interpretive software, professional-only
OXEHEALTH LIMITED
2
In Commercial Distribution

  • 50607514500023 ()


  • Sleep disorder interpretive software, professional-only

Lumax™ - 60888937013445

Lumax™ Software Update pack
Coopersurgical, Inc.
53361
In Commercial Distribution

  • 60888937013445 ()


  • Urodynamic measurement system

Vue RIS - 60889978671366

RIS SOFTWARE < 25K EXAMS / YEAR
CARESTREAM HEALTH, INC.
Vue RIS
In Commercial Distribution

  • 60889978671366 ()
8671364

  • Radiology information system application software

PROFESS - 07613327071955

PROFESS(TM) SOFTWARE SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-81033
In Commercial Distribution

  • 07613327071955 ()
81-81033

  • Robotic surgical navigation system application software

NA - 07613327311822

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

  • 07613327311822 ()
0101-0001

  • Medical image management system

NA - 07613154481118

FLUOROSCOPY SOFTWARE 2.3 CD-SALES DEMO
Stryker Leibinger GmbH & Co. KG
81-80037
In Commercial Distribution

  • 07613154481118 ()
81-80037

  • Robotic surgical navigation system application software

Sherlock 3CG+, BD SiteRite 9 Ultrasound System - 00801741231124

Site~Rite 9 Ultrasound Software
Bard Access Systems, Inc.
SR9v1.1.0
In Commercial Distribution

  • 00801741231124 ()
SR9v1.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system

Sherlock 3CG+, BD SiteRite 9 Ultrasound System - 00801741219221

SiteRite 9 Sherlock Software v3.3.1
Bard Access Systems, Inc.
Sherlockv3.3.1
In Commercial Distribution

  • 00801741219221 ()
Sherlockv3.3.1

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system

Vivo 50, VIvo 65 - 07321820051007

Vivo 50/65 PC Software
Breas Medical AB
005100
In Commercial Distribution

  • 07321820051007 ()
005100

  • Medical equipment clinical data interfacing software
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