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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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Q-Tel RMS - 00817655021447

Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-006-70
In Commercial Distribution

  • 00817655021447 ()


  • Electrocardiography telemetric monitoring system

Q-Tel RMS - 00817655021430

Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-005-70
In Commercial Distribution

  • 00817655021430 ()


  • Electrocardiography telemetric monitoring system

Q-Tel RMS - 00817655020105

Software accessory cleared with Q-Tel RMS
MORTARA INSTRUMENT, INC.
11089-001-70
In Commercial Distribution

  • 00817655020105 ()


  • Electrocardiography telemetric monitoring system

Zvu - 00816734022429

Zvu® Advanced GI Diagnostic Software
DIVERSATEK HEALTHCARE, INC.
ZVU-2016
In Commercial Distribution

  • 00816734022429 ()
  • B019ZVU20160 ()
ZVU-2016

  • Manometric gastrointestinal motility analysis system

Sherlock 3CG+ TCS - 00801741188718

Sherlock 3CG+ TCS Software Version 3.1.0
Bard Access Systems, Inc.
Sherlock 3CG+ TCS Software Version 3.1.0
In Commercial Distribution

  • 00801741188718 ()
Sherlock 3CG+ TCS Software Version 3.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic

Site~Rite 8 Ultrasound System - 00801741225895

Site~Rite 8 Software v. 3.0.1
Bard Access Systems, Inc.
SR8v3.0.1
In Commercial Distribution

  • 00801741225895 ()
SR8v3.0.1

  • General-purpose ultrasound imaging system

Site~Rite 8 - 00801741219436

Site~Rite 8 Sherlock Application Software
Bard Access Systems, Inc.
Sherlockv3.1.1
In Commercial Distribution

  • 00801741219436 ()
Sherlockv3.1.1

  • Central venous catheter navigation system, electrocardiographic/magnetic

Site~Rite 8 Ultrasound System - 00801741219382

Site~Rite 8 Software v. 2.3.1
Bard Access Systems, Inc.
SR8v2.3.1
In Commercial Distribution

  • 00801741219382 ()
SR8v2.3.1

  • General-purpose ultrasound imaging system

Site~Rite 8 - 00801741219344

Site~Rite 8 Host System Software
Bard Access Systems, Inc.
SR8v2.2.0
In Commercial Distribution

  • 00801741219344 ()
SR8v2.2.0

  • General-purpose ultrasound imaging system

Site~Rite 8 - 00801741219252

Site~Rite 8 Ultrasound Application Software
Bard Access Systems, Inc.
SR8 USv2.2.0
In Commercial Distribution

  • 00801741219252 ()
SR8 USv2.2.0

  • General-purpose ultrasound imaging system
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