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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 - 04056719000127

BodyFIX® Manifold Cushion 900mm prevents the Cover Sheet from collapsing directly against the vacuum tube by distributing the airflow around the patient.
3C-Medical Intelligence GmbH
P10102-203
In Commercial Distribution

  • 04056719000127 ()
P10102-203

  • Vacuum-mould patient positioning system

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

NA - 04055207013441

RIWO-NET SPEECH CONTROL UK-ENG
Richard Wolf GmbH
5590976
Not in Commercial Distribution

  • 04055207013441 ()
5590.976

  • Operating room audiovisual data/device management system

NA - 04055207013434

RIWO-NET SPEECH CONTROL SPAN
Richard Wolf GmbH
5590975
Not in Commercial Distribution

  • 04055207013434 ()
5590.975

  • Operating room audiovisual data/device management system

NA - 04055207013427

RIWO-NET SPEECH CONTROL ITAL
Richard Wolf GmbH
5590974
Not in Commercial Distribution

  • 04055207013427 ()
5590.974

  • Operating room audiovisual data/device management system

NA - 04055207013410

RIWO-NET SPEECH CONTROL FRENCH
Richard Wolf GmbH
5590973
Not in Commercial Distribution

  • 04055207013410 ()
5590.973

  • Operating room audiovisual data/device management system

NA - 04055207013403

RIWO-NET SPEECH CONTROL US-ENG
Richard Wolf GmbH
5590972
Not in Commercial Distribution

  • 04055207013403 ()
5590.972

  • Operating room audiovisual data/device management system

NA - 04055207013397

RIWO-NET SPEECH CONTROL DE
Richard Wolf GmbH
5590971
Not in Commercial Distribution

  • 04055207013397 ()
5590.971

  • Operating room audiovisual data/device management system

NA - 04055207013359

CAN-INTERFACE SERIAL DEVICES reusable
Richard Wolf GmbH
5590817
Not in Commercial Distribution

  • 04055207013359 ()
5590817

  • Operating room audiovisual data/device management system

NA - 04055207013342

CAN-INTERFACE SERIAL DEVICES reusable
Richard Wolf GmbH
5590816
Not in Commercial Distribution

  • 04055207013342 ()
5590.816

  • Operating room audiovisual data/device management system

NA - 04055207013335

CAN-INTERFACE OR-TABLE Interface module allows controlling OR tables of company Trumpf and Maquet. Controllable models Trumpf: Titan, Jupiter, Jupiter, Universal Carbon, Mars, Mars Endouro, Saturn Select, TruSystem 5500, TruSystem 7500 Controllable models Maquet: 1132 Alphastar, 1133 Alphamaxx, 1150 Alphamaquet, 113112 Betastar Dim (WxHxD) in mm: 215 x 38 x 120 WT: 420g, Mains voltage 12V DC / 0,5A Available since core.software release 5.0
Richard Wolf GmbH
5590815
Not in Commercial Distribution

  • 04055207013335 ()
5590.815

  • Operating room audiovisual data/device management system

n.a. - 04048551326510

Karl Storz Video Editor
Karl Storz GmbH & Co. KG
20040445-V02
In Commercial Distribution

  • 04048551326510 ()


  • Operating room audiovisual data/device management system

n.a. - 04048551325117

SCB control NEO Software Upgrade
Karl Storz GmbH & Co. KG
20090001S432
In Commercial Distribution

  • 04048551325117 ()


  • Operating room audiovisual data/device management system

n.a. - 04048551309841

SCB/Maquet II OR Table Interface Box
Karl Storz GmbH & Co. KG
20092832
In Commercial Distribution

  • 04048551309841 ()


  • Operating room audiovisual data/device management system

n.a. - 04048551282113

SCB Maquet Power LED OR Light Module
Karl Storz GmbH & Co. KG
20092722
In Commercial Distribution

  • 04048551282113 ()


  • Operating room audiovisual data/device management system

n.a. - 04048551265666

SCB Universal OR Table interface module
Karl Storz GmbH & Co. KG
20092522
In Commercial Distribution

  • 04048551265666 ()


  • Operating room audiovisual data/device management system

DURAY - 00837699000109

DC1, Duray Scanner DC1 Package
Beyes Dental Canada Inc
DC1001
In Commercial Distribution

  • 00837699000109 ()


  • Dental computed radiography digital imaging scanner

VacFix Pump - B790VFPUMP0

The VacFix Pump is a device used to remove air from vacuum fixation cushions.
TALON
VF-PUMP
In Commercial Distribution

  • B790VFPUMP0 ()
VF-PUMP

  • Vacuum-mould patient positioning system

BIONIX RADIATION THERAPY - 00817740021178

CF MEDICAL INTELLIGENCE SECUREFIT BAR
Bionix Radiation Therapy, LLC
UTRT-7019
Not in Commercial Distribution

  • 00817740021178 ()
UTRT-7019

  • Vacuum-mould patient positioning system

BIONIX RADIATION THERAPY - 00817740020119

SECURE FIT BAR: HEAD AND NECK
Bionix Radiation Therapy, LLC
UTRT-5012A
Not in Commercial Distribution

  • 00817740020119 ()
UTRT-5012A

  • Vacuum-mould patient positioning system

BIONIX RADIATION THERAPY - 00817740020843

ELEKTA SECUREFIT BAR
Bionix Radiation Therapy, LLC
UTRT-5018
Not in Commercial Distribution

  • 00817740020843 ()
UTRT-5018

  • Vacuum-mould patient positioning system

BIONIX RADIATION THERAPY - 00817740020836

SIEMENS SECUREFIT BAR
Bionix Radiation Therapy, LLC
UTRT-5016
Not in Commercial Distribution

  • 00817740020836 ()
UTRT-5016

  • Vacuum-mould patient positioning system

BIONIX RADIATION THERAPY - 00817740020829

SECUREFIT SLIDER ATTACHMENT
Bionix Radiation Therapy, LLC
UTRT-5015
Not in Commercial Distribution

  • 00817740020829 ()
UTRT-5015

  • Vacuum-mould patient positioning system

BIONIX RADIATION THERAPY - 00817740020812

SECUREVAC ADAPTOR
Bionix Radiation Therapy, LLC
UTRT-5014A
Not in Commercial Distribution

  • 00817740020812 ()
UTRT-5014A

  • Vacuum-mould patient positioning system

BIONIX RADIATION THERAPY - 00817740020805

VARIAN SECURE FIT BAR
Bionix Radiation Therapy, LLC
UTRT-5010A
Not in Commercial Distribution

  • 00817740020805 ()
UTRT-5010A

  • Vacuum-mould patient positioning system

BIONIX RADIATION THERAPY - 00817740020799

NUCLETRON BAR
Bionix Radiation Therapy, LLC
UTRT-5009
Not in Commercial Distribution

  • 00817740020799 ()
UTRT-5009

  • Vacuum-mould patient positioning system

BIONIX RADIATION THERAPY - 00817740020782

GE SECUREFIT BAR
Bionix Radiation Therapy, LLC
UTRT-5008
Not in Commercial Distribution

  • 00817740020782 ()
UTRT-5008

  • Vacuum-mould patient positioning system

BIONIX RADIATION THERAPY - 00817740020775

PHILLIPS SECUREFIT BAR
Bionix Radiation Therapy, LLC
UTRT-5007
Not in Commercial Distribution

  • 00817740020775 ()
UTRT-5007

  • Vacuum-mould patient positioning system

ScanX Swift View 2.0 - E247G8900

Dental Image Plate Scanner
DÜRR DENTAL SE
XPS07.2A1
In Commercial Distribution

  • E247G8900 ()
G8900, G8900A

  • Dental computed radiography digital imaging scanner

ScanX Swift 2.0 - E247G8800

Dental Image Plate Scanner
DÜRR DENTAL SE
XPS07.1A1
In Commercial Distribution

  • E247G8800 ()
G8800, G8800A

  • Dental computed radiography digital imaging scanner
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