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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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TPI-S ANALOG ASSY CONDOR MED
Smith & Nephew, Inc.
72200043
Not in Commercial Distribution

  • 00885554011579 ()
72200043

  • Operating room audiovisual data/device management system
No Description
medPhoton GmbH
1.2
In Commercial Distribution

  • 19120075320037 ()


  • Computed radiography digital imaging scanner
No Description
medPhoton GmbH
1.1
In Commercial Distribution

  • 19120075320013 ()


  • Computed radiography digital imaging scanner
Klarity Vacuum Bag 100cm x 70cm, 17.5 liter fill, with Civco-style valve
Klarity Medical Products, LLC
R7504-17.5C
In Commercial Distribution

  • 00817355029842 ()


  • Vacuum-mould patient positioning system
Nylon bag (100 x 200cm, 120L)
MEDTEC, INC.
VLH120C
Not in Commercial Distribution

  • 00841439112342 ()
VLH120C

  • Vacuum-mould patient positioning system
Paradigm System Cart, 120-volt
Proprio, Inc.
1100006
In Commercial Distribution

  • 00850042604014 ()
1100006

  • Optical surgical navigation device tracking system
  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software
Paradigm System Cart
Proprio, Inc.
1100001
Not in Commercial Distribution

  • 00850042604007 ()
  • 10850042604004 ()
1100003

  • Optical surgical navigation device tracking system
  • Surgical planning/navigation-enhancement system
  • Stereotactic system application software
Manometer, Wall Mount Swivel Mount, w/Arm (4.5"x180° Rot.) w/Hardware, fits all 00-199, 00-274 Gauges
ANESTHESIA ASSOCIATES, INC.
00-196
In Commercial Distribution

  • B005001960 ()
00-196

  • Airway pressure monitor, non-powered
The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.X
In Commercial Distribution

  • 00859699006059 ()


  • Patient health record information system
  • Radiological PACS software
The Surgimap® software assists healthcare professionals in viewing, storing, and measuring images as well as planning orthopedic surgeries. The device allows service providers to perform generic as well as specialty measurements of the images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants, and offer online synchronization of the database with the possibility to share data among Surgimap® users. Clinical judgment and experience are required to properly use the software.
NEMARIS, INC
2.2.9.X
In Commercial Distribution

  • 00859699006042 ()


  • Radiological PACS software
  • Patient health record information system
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