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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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No Description
MATH RESOLUTIONS, LLC
5
In Commercial Distribution

  • B229DC051 ()


  • Radiation therapy software
Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
5
In Commercial Distribution

  • B185FS059370 ()


  • Psychophysiological biofeedback system
Tinted Glow Powder
JBC and Company
5
In Commercial Distribution

  • D85105 ()
5-2

  • Dental appliance fabrication material, resin
No Description
QIAGEN GmbH
5
In Commercial Distribution

  • 04053228045809 ()
62724

  • Nucleic acid extraction/isolation kit IVD
Professional acquisition software for the connection and control of a direct radiography detector (DR) with an up to date graphic user interface, intuitive operation via touch screen and an adaptable organ specific image processing. It also includes a diagnostic module standard and the multimedia radiographic positioning guide.
Oehm und Rehbein GmbH
5
Not in Commercial Distribution

  • 04250802900411 ()
SW1000

  • Diagnostic x-ray digital imaging system workstation application software
  • Radiology DICOM image processing application software
  • Basic diagnostic x-ray system application software
Cloud based DICOM picture archiving system
Oehm und Rehbein GmbH
5
In Commercial Distribution

  • 04250802900169 ()
OC1000

  • Radiology DICOM image processing application software
No Description
Heine Optotechnik GmbH & Co. KG
5
In Commercial Distribution

  • 04053755200238 ()
F-000.22.105

  • Laryngoscope blade, reusable
No Description
Carl Zeiss Meditec AG
5
In Commercial Distribution

  • 04049539070302 ()


  • Operating room audiovisual data/device management system
FRESH WHOLE BLOOD TRANSFUSION SET Donor Set (PN 80-801-D) 1ea Recipient Set (PN 80-801-R) 1ea Instructions for Use 1ea
Safeguard US Operating, LLC
5
In Commercial Distribution

  • M68980801050 ()
80-801

  • Blood transfusion set, non-exchange
  • Blood donor set, single-pack
1ea. - 6' x 4", clear, self-adhering, compression wrap
Safeguard US Operating, LLC
5
Not in Commercial Distribution

  • M68902001050 ()
02-001

  • Pressure bandage, non-latex, single-use
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