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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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Millennium - 00190776384876

Double Ended Orbital Retractor, small, 10mm /14mm
Avalign Technologies, Inc.
1-3706
In Commercial Distribution

  • 00190776384876 ()


  • Telemetric sphygmomanometer

Millennium - 00190776384869

Double Ended Orbital Retractor, large, 16mm/ 25mm
Avalign Technologies, Inc.
1-3705
In Commercial Distribution

  • 00190776384869 ()


  • Telemetric sphygmomanometer

Millennium - 00190776384845

Desmarres Lid Retractor, 5 1/2", 15mm, coated
Avalign Technologies, Inc.
1-210196NC
In Commercial Distribution

  • 00190776384845 ()


  • Telemetric sphygmomanometer

Millennium - 00190776384838

Desmarres Lid Retractor, 5 1/2", 11mm, coated
Avalign Technologies, Inc.
1-210194NC
In Commercial Distribution

  • 00190776384838 ()


  • Telemetric sphygmomanometer

QFlow 500 Perfusion Probe - B238H000016000

Thermal Diffusion Probe
HEMEDEX, INC
NA
In Commercial Distribution

  • B238H000016000 ()
H0000-1600

  • Patient monitoring system module, intracranial pressure

Sonoma Orthopedic Products, Inc - 00816988010326

3.5mm Syndesmotic Drill, Non-sterile
ARTHREX, INC.
IN0066
Not in Commercial Distribution

  • 00816988010326 ()
IN0066

  • Patient monitoring system module, printing

Zvu® - 00816734022733

Zvu® HRAM Probe
DIVERSATEK HEALTHCARE, INC.
HRAM-200
In Commercial Distribution

  • 00816734022733 ()

  • Catheter Gauge: 17 French
HRAM-200

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022689

Zvu® HRiM Probe
DIVERSATEK HEALTHCARE, INC.
HRIM-201
In Commercial Distribution

  • 00816734022689 ()

  • Catheter Gauge: 12 French
HRIM-201

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022924

Zvu® HRAM Starter Kit
DIVERSATEK HEALTHCARE, INC.
HRAM-200-17-KIT
In Commercial Distribution

  • 00816734022924 ()

  • Catheter Gauge: 17 French
HRAM-200-17-KIT

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022917

Zvu® HRiM Probe Kit
DIVERSATEK HEALTHCARE, INC.
HRIM-201-12-KIT
In Commercial Distribution

  • 00816734022917 ()

  • Catheter Gauge: 12 French
HRIM-201-12-KIT

  • Manometric gastrointestinal motility analysis system
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