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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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extriCARE - 00879766005617

NPWT Bandage-Small oval tubing set
OAKWELL DISTRIBUTION, INC.
EC2400-SO
In Commercial Distribution

  • 20879766005611 ()
  • 00879766005617 ()


  • Multi-purpose low-vacuum suction system

extriCARE - 00879766005600

NPWT Bandage-Large oval tubing set
OAKWELL DISTRIBUTION, INC.
EC2400-LO
In Commercial Distribution

  • 20879766005604 ()
  • 00879766005600 ()


  • Multi-purpose low-vacuum suction system

MAR - 00195278303219

MAR Application Container for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.1
In Commercial Distribution

  • 00195278303219 ()


  • CT system application software

ASiR-V - 00195278303196

ASiR-V Application Container for Smart Subscription
GE HEALTHCARE JAPAN CORPORATION
1.1
In Commercial Distribution

  • 00195278303196 ()


  • CT system application software

ACRYSOF, IQ RESTOR - 00380659909474

AcrySof IQ ReSTOR Multifocal Toric IOL +3.0 D IOL Calculator
Alcon Laboratories, Inc.
Version 1.0
In Commercial Distribution

  • 00380659909474 ()


  • Intraocular lens calculation software

Digital Imaging System, Nexus DR, v4.2.0 - 00854344007405

No Description
VAREX IMAGING CORPORATION
Nexus DR v4.2.0
In Commercial Distribution

  • 00854344007405 ()


  • X-ray system computer, diagnostic, general-purpose

Varex Digital Imaging System, Nexus DR v4.1.0 - 00854344007221

No Description
VAREX IMAGING CORPORATION
Nexus DR v4.1.0
In Commercial Distribution

  • 00854344007221 ()


  • X-ray system computer, diagnostic, general-purpose

Hokanson - 00817065021532

ARTERIAL AND VENOUS EXAM, W/DOPPLER SPECTRA SOFTWARE - 220V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease diagnosis in the patient. Includes interface box to connect computer to physiologic instruments and 220V mains.
D.E.HOKANSON, INC.
5.40
In Commercial Distribution

  • 00817065021532 ()
03417

  • Peripheral vascular haemodynamic measurement application software

iotaSOFT Insertion System - 00850002960068

iotaSOFT Plus Drive Unit
Iotamotion, Inc.
IM-05
In Commercial Distribution

  • 00850002960068 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960006

iotaSOFT Drive Unit
Iotamotion, Inc.
IM-00
In Commercial Distribution

  • 00850002960006 ()


  • Robotic surgical system application software
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