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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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BodyFIX - 04056719000110

BodyFIX® Manifold Cushion 800mm prevents the Cover Sheet from collapsing directly against the vacuum tube by distributing the airflow around the patient.
3C-Medical Intelligence GmbH
P10102-202
In Commercial Distribution

  • 04056719000110 ()
P10102-202

  • Vacuum-mould patient positioning system

BodyFIX - 04056719000103

BodyFIX® Manifold Cushion 700mm prevents the Cover Sheet from collapsing directly against the vacuum tube by distributing the airflow around the patient.
3C-Medical Intelligence GmbH
P10102-201
In Commercial Distribution

  • 04056719000103 ()
P10102-201

  • Vacuum-mould patient positioning system

BodyFIX - 04056719000097

BodyFIX® Manifold Cushion 600mm prevents the Cover Sheet from collapsing directly against the vacuum tube by distributing the airflow around the patient.
3C-Medical Intelligence GmbH
P10102-200
In Commercial Distribution

  • 04056719000097 ()
P10102-200

  • Vacuum-mould patient positioning system

BodyFIX - 04056719000080

BodyFix® Vacuum Pump P3 is a vacuum pump that controls the dual-vacuum technology, used for precise patient positioning and immobilization of the BodyFIX® System.
3C-Medical Intelligence GmbH
P10102-150
In Commercial Distribution

  • 04056719000080 ()
P10102-150

  • Vacuum-mould patient positioning system

BodyFIX - 04056719000073

BodyFIX® Diaphragm Control has been developed to specifically minimize diaphragm movements.
3C-Medical Intelligence GmbH
P10102-119
In Commercial Distribution

  • 04056719000073 ()
P10102-119

  • Vacuum-mould patient positioning system

BodyFIX - 04056719000066

BodyFIX® 14 Target Positioner STANDARD enables the exact targeting of the tumor isocenter on the linac identified with the localizer on the CT.
3C-Medical Intelligence GmbH
P10102-115
In Commercial Distribution

  • 04056719000066 ()
P10102-115

  • Vacuum-mould patient positioning system

BodyFIX - 04056719000059

BodyFIX® 14 Localizer STANDARD enables precise localization of the tumor isocenter. The x-, y-, z-isocenter coordinates can easily be determined with the rods of the localizer.
3C-Medical Intelligence GmbH
P10102-114
In Commercial Distribution

  • 04056719000059 ()
P10102-114

  • Vacuum-mould patient positioning system

BodyFIX - 04056719000042

BodyFIX® 14 Base Plate Stereotactic MRI is specially designed for using BodyFIX stereotactic on non-indexed MRI couchtops.
3C-Medical Intelligence GmbH
P10102-113
Not in Commercial Distribution

  • 04056719000042 ()
P10102-113

  • Vacuum-mould patient positioning system

BodyFIX - 04056719000035

BodyFIX® 14 Base Plate Stereotactic Standard is specially designed for using BodyFIX stereotactic on non-indexed couchtops.
3C-Medical Intelligence GmbH
P10102-112
In Commercial Distribution

  • 04056719000035 ()
P10102-112

  • Vacuum-mould patient positioning system

BodyFIX - 04056719000028

BodyFIX® Comfort Module 500x400mm is a cushion to place the head and upper body comfortably on the couchtop where no BlueBAG is beyond the patient’s body.
3C-Medical Intelligence GmbH
P10102-102
In Commercial Distribution

  • 04056719000028 ()
P10102-102

  • Vacuum-mould patient positioning system

BodyFIX - 04056719000011

BodyFIX® Comfort Module 500x200mm is a cushion to place the head and upper body comfortably on the couchtop where no BlueBAG is beyond the patient’s body.
3C-Medical Intelligence GmbH
P10102-101
In Commercial Distribution

  • 04056719000011 ()
P10102-101

  • Vacuum-mould patient positioning system

CALLISTO eye - 04049539104410

No Description
Carl Zeiss Meditec AG
3.7
In Commercial Distribution

  • 04049539104410 ()


  • Operating room audiovisual data/device management system

CALLISTO eye - 04049539104403

No Description
Carl Zeiss Meditec AG
3.6.2
In Commercial Distribution

  • 04049539104403 ()


  • Operating room audiovisual data/device management system

CALLISTO eye - 04049539104366

No Description
Carl Zeiss Meditec AG
CALLISTO eye
In Commercial Distribution

  • 04049539104366 ()


  • Operating room audiovisual data/device management system

CALLISTO eye - 04049539102423

No Description
Carl Zeiss Meditec AG
3.2.1
In Commercial Distribution

  • 04049539102423 ()


  • Operating room audiovisual data/device management system

CALLISTO eye Software - 04049539070302

No Description
Carl Zeiss Meditec AG
5
In Commercial Distribution

  • 04049539070302 ()


  • Operating room audiovisual data/device management system

CALLISTO eye - 04049539069092

No Description
Carl Zeiss Meditec AG
3.5.1
In Commercial Distribution

  • 04049539069092 ()


  • Operating room audiovisual data/device management system

Genoray - 08809244060076

No Description
GENORAY CO., LTD.
GenX-CR
In Commercial Distribution

  • 08809244060076 ()


  • Computed radiography digital imaging scanner

FireCR Spark - 08809466040511

The FireCR Spark System is ideal for Computed Radiography examinations in busy clinics and specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR Spark System enables all imaging functions to be performed with the advanced image management software, a solution that can be adapted most clinical applications.
Digiray Corp.
FR31
In Commercial Distribution

  • 08809466040511 ()

  • Height: 13.4 Centimeter
  • Length: 79.5 Centimeter
  • Width: 44.4 Centimeter
  • Weight: 21.5 Kilogram
CG-301

  • Computed radiography digital imaging scanner

FireCR Flash - 08809466040412

The FireCR Flash can be configured for nearly every clinical application, and is designed for full DICOM connectivity, and allows user to setup the system to capture high quality X-ray images of any body parts with minimal steps including reading, processing, displaying and sending of the high quality image. All imaging parameters are optimized, resulting in digital images that can be enhanced, enlarged, duplicated, and sent to any location as a DICOM 3.0 file format in seconds with no loss of resolution.
Digiray Corp.
FR41
In Commercial Distribution

  • 08809466040412 ()

  • Weight: 21.5 Kilogram
  • Width: 44.4 Centimeter
  • Length: 79.5 Centimeter
  • Height: 13.4 Centimeter
CG-401

  • Computed radiography digital imaging scanner

FireCR Spark - 08809466040313

The FireCR Spark System is ideal for Computed Radiography examinations in busy clinics and specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR Spark System enables all imaging functions to be performed with the advanced image management software, a solution that can be adapted most clinical applications.
Digiray Corp.
FR31
In Commercial Distribution

  • 08809466040313 ()

  • Weight: 21.5 Kilogram
  • Width: 44.4 Centimeter
  • Length: 79.5 Centimeter
  • Height: 13.4 Centimeter
CG-301

  • Computed radiography digital imaging scanner

FireCR Dental - 08809466040214

The advanced CR technology of the FireCR Dental Reader enables you to produce high-quality digital images for diagnosing the patients in your facility. The reader can be used as a central reader, which distributes images throughout your facility, or as an exam-room based solution. The reader is DICOM 3.0 compatible with existing systems and uses a full range of low-cost, reusable bitewings and intraoral imaging plates. The design features a built-in erase function and a color touch-screen LCD panel without physical push buttons for seamless device operation.
Digiray Corp.
FR11
In Commercial Distribution

  • 08809466040214 ()

  • Weight: 4.7 Kilogram
  • Width: 12.0 Centimeter
  • Length: 31.8 Centimeter
  • Height: 26.5 Centimeter
CG-702

  • Computed radiography digital imaging scanner

SYSTEM, X-RAY, STATIONARY - 08809246620032

TITAN 11 is a diagnostic DR System that contains high output capacity and high-resolution image processing system. During a surgery, the presence of lesions, size, and location can be recorded easily as Radiography images. The important images can be stored within the device so taking Radiography images is convenient.
GEMSS MEDICAL SYSTEMS CO.,LTD.
TITAN 11
In Commercial Distribution

  • 08809246620032 ()
TITAN 11

  • Computed radiography digital imaging scanner

Vac-Lok™ Cushion - 00841439113868

Nylon bag (75 x 120cm, 25L) with indexing for pelvic positioning
MEDTEC, INC.
VLPLV10FC
In Commercial Distribution

  • 00841439113868 ()
VLPLV10FC

  • Vacuum-mould patient positioning system

Vac-Lok™ Cushion - 00841439113851

Nylon bag (75 x 100cm, 21L) with indexing for pelvic positioning
MEDTEC, INC.
VLPLV09FC
In Commercial Distribution

  • 00841439113851 ()
VLPLV09FC

  • Vacuum-mould patient positioning system

Vac-Lok™ Cushion - 00841439113844

75 x 100cm, 25L, nylon bag for pelvic positioning
MEDTEC, INC.
VLPLV10C
In Commercial Distribution

  • 00841439113844 ()
VLPLV10C

  • Vacuum-mould patient positioning system

Vac-Lok™ Cushion - 00841439113837

75 x 100cm, 21L, nylon bag for pelvic positioning
MEDTEC, INC.
VLPLV09C
In Commercial Distribution

  • 00841439113837 ()
VLPLV09C

  • Vacuum-mould patient positioning system

Vac-Lok™ Cushion - 00841439113820

"T" shape nylon bag (108 x 125cm, 31L)
MEDTEC, INC.
VL0022
In Commercial Distribution

  • 00841439113820 ()
VL0022

  • Vacuum-mould patient positioning system

Vac-Lok™ Cushion - 00841439113813

Nylon bag with indexing (70 x 100cm, 26L)
MEDTEC, INC.
VLG26FC
In Commercial Distribution

  • 00841439113813 ()
VLG26FC

  • Vacuum-mould patient positioning system

Vac-Lok™ Cushion - 00841439113806

Nylon bag (100 x 200cm, 90L)
MEDTEC, INC.
VLH90C
In Commercial Distribution

  • 00841439113806 ()
VLH90C

  • Vacuum-mould patient positioning system
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