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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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FUJI IP CASSETTE CC - 04547410049435

The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
FUJIFILM CORPORATION
CC BWPB 35.4X43.0cm(14X17)
In Commercial Distribution

  • 14547410049432 ()
  • 04547410049435 ()

  • 35.4X43.0 CM


  • Computed radiography digital imaging scanner

FUJIFILM IP CASSETTE Type UR Adapter - 04547410049213

No Description
FUJIFILM CORPORATION
24X30CM
In Commercial Distribution

  • 04547410049213 ()


  • Computed radiography digital imaging scanner

FDR ES II C25 - 04547410549300

The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1285 SE FF E
In Commercial Distribution

  • 04547410549300 ()


  • Diagnostic x-ray digital imaging conversion system

FDR ES II C43 - 04547410549294

The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1284 SE FF E
In Commercial Distribution

  • 04547410549294 ()


  • Diagnostic x-ray digital imaging conversion system

FDR ES II C35 - 04547410549287

The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1283 SE FF E
In Commercial Distribution

  • 04547410549287 ()


  • Diagnostic x-ray digital imaging conversion system

FDR ES II G43 - 04547410549270

The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1282 SE FF E
In Commercial Distribution

  • 04547410549270 ()


  • Diagnostic x-ray digital imaging conversion system

FDR ES II G35 - 04547410549263

The Flat Panel Sensor (DR-ID 128xSE) is intended for healthcare professionals engaged in radiography to capture and output the digital radiographic images for diagnosis to other devices. The Flat Panel Sensor (DR-ID 128xSE) is not intended for mammography, fluoroscopy, tomography, and angiography applications.
FUJIFILM CORPORATION
DR-ID 1281 SE FF E
In Commercial Distribution

  • 04547410549263 ()


  • Diagnostic x-ray digital imaging conversion system

FUJIFILM AP - 04547410545883

This product is used to establish wireless communication between a specific flat panel sensor and image processing unit.
FUJIFILM CORPORATION
DR-ID 1280 AP KIT E
In Commercial Distribution

  • 04547410545883 ()


  • Diagnostic x-ray digital imaging conversion system

Li-polymer BATTERY CHARGER - 04547410530667

This product is used to charge Li-Polymer Battery set in this product.
FUJIFILM CORPORATION
DR1280 SE BATTERY CHARGER E
In Commercial Distribution

  • 04547410530667 ()


  • Diagnostic x-ray digital imaging conversion system

CR MULTIFORMAT READER - 05414904160480

CR MULTIFORMAT READER
AGFA
5151/310
In Commercial Distribution

  • 05414904160480 ()
5YECJ

  • Computed radiography digital imaging scanner

CR 15-X - 05414904160473

CR 15-X DIGITIZER
AGFA
5151/300
In Commercial Distribution

  • 05414904160473 ()
5YEBG

  • Computed radiography digital imaging scanner

CR ADVANCED READER - 05414904151327

CR ADVANCED READER
AGFA
5151/210
In Commercial Distribution

  • 05414904151327 ()
5W8DH

  • Computed radiography digital imaging scanner

CR 12-X - 05414904151310

CR 12-X DIGITIZER
AGFA
5151/200
In Commercial Distribution

  • 05414904151310 ()
5W8AB

  • Computed radiography digital imaging scanner

CR READER - 05414904151303

CR READER
AGFA
5151/110
In Commercial Distribution

  • 05414904151303 ()
5W784

  • Computed radiography digital imaging scanner

CR 10-X - 05414904092514

CR 10-X DIGITIZER
AGFA
5151/100
In Commercial Distribution

  • 05414904092514 ()
5R3EQ

  • Computed radiography digital imaging scanner

DX-M - 05414904050385

DX-M DIGITIZER
AGFA
5170/200
In Commercial Distribution

  • 05414904050385 ()
E4YW2

  • Computed radiography digital imaging scanner

Peezy Non-sterile specimen mailer and storage container PE 51 Boric - 05060423410935

Urine Collection Kit
BODDINGTONS PLASTICS LIMITED
PE 51 Boric
In Commercial Distribution

  • 05060423410942 ()
  • 05060423410935 ()


  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034822

MNA-420 DEC HDMI V2 INC SFP+ UK
Barco NV
MNA-420
In Commercial Distribution

  • 05415334034822 ()
K9350202G

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034266

MNA-440 DEC HDMI V2 INC SFP+ UK
Barco NV
MNA-440
In Commercial Distribution

  • 05415334034266 ()
K9350204G

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334033030

NEXXIS SYSTEM X670 CM V3
Barco NV
Nexxis
In Commercial Distribution

  • 05415334033030 ()
K9605027

  • Operating room audiovisual data/device management system

Barco - 05415334053670

VANTAGEVIEW 2.0 ENCODER HD
Barco NV
MNA-420
In Commercial Distribution

  • 05415334053670 ()
600306027

  • Operating room audiovisual data/device management system

Barco - 05415334053663

VANTAGEVIEW 2.0 DECODER
Barco NV
MNA-240
In Commercial Distribution

  • 05415334053663 ()
600301482

  • Operating room audiovisual data/device management system

Barco - 05415334053472

VANTAGEVIEW 2.0 ANALOG ENCODER
Barco NV
MNA-120
In Commercial Distribution

  • 05415334053472 ()
600301481

  • Operating room audiovisual data/device management system

Barco - 05415334053458

VANTAGEVIEW 2.0 ENCODER 4K
Barco NV
MNA-440
In Commercial Distribution

  • 05415334053458 ()
600301479

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334050839

MNA-420 DEC HDMI V2
Barco NV
MNA-420
In Commercial Distribution

  • 05415334050839 ()
K9303331CMS

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334050822

MNA-440 DEC HDMI V2
Barco NV
MNA-440
In Commercial Distribution

  • 05415334050822 ()
K9303311CMS

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334050815

MNA-420 ENC HDMI
Barco NV
MNA-420
In Commercial Distribution

  • 05415334050815 ()
K9303320CMS

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334042346

NEXXIS WORKSPOT KIT2 CM
Barco NV
Nexxis system
In Commercial Distribution

  • 05415334042346 ()
K9610424

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334039131

NEXXIS SYSTEM X670 CM V6
Barco NV
NEXXIS system
In Commercial Distribution

  • 05415334039131 ()
k9605033

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334039124

NEXXIS SYSTEM X620 CM V6
Barco NV
NEXXIS system
In Commercial Distribution

  • 05415334039124 ()
k9605034

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334037687

MNA-440 ENC SDI IN
Barco NV
MNA-440
In Commercial Distribution

  • 05415334037687 ()
k9303301D

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334037632

MNA-420 ENC HDMI IN
Barco NV
MNA-420
In Commercial Distribution

  • 05415334037632 ()
k9303320D

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334037625

MNA-420 DEC HDMI V2 IN
Barco NV
MNA-420
In Commercial Distribution

  • 05415334037625 ()
k9303331D

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334036840

NEXXIS WORKSPOT KIT CM
Barco NV
NEXXIS system
In Commercial Distribution

  • 05415334036840 ()
K9610421

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334036833

NEXXIS SYSTEM X620 CM V5
Barco NV
NEXXIS system
In Commercial Distribution

  • 05415334036833 ()
K9605032

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334036826

NEXXIS SYSTEM X670 CM V5
Barco NV
NEXXIS system
In Commercial Distribution

  • 05415334036826 ()
K9605031

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334036277

NEXXIS ULTIMAX KIT
Barco NV
Nexxis system
In Commercial Distribution

  • 05415334036277 ()
K9610420

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034891

NEXXIS SYSTEM X670 CM V4
Barco NV
Nexxis system
In Commercial Distribution

  • 05415334034891 ()
K9605029

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034877

NEXXIS SYSTEM X620 CM V4
Barco NV
Nexxis system
In Commercial Distribution

  • 05415334034877 ()
K9605030

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034846

MNA-420 DEC HDMI V2 INC SFP+ US
Barco NV
MNA-420
In Commercial Distribution

  • 05415334034846 ()
K9350202B

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034839

MNA-420 DEC HDMI V2 INC SFP+ EU
Barco NV
MNA-420
In Commercial Distribution

  • 05415334034839 ()
K9350202F

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034815

MNA-420 DEC HDMI V2 INC SFP+ CN
Barco NV
MNA-420
In Commercial Distribution

  • 05415334034815 ()
K9350202I

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034303

MNA-420 DEC HDMI V2 INC SFP+ XX
Barco NV
MNA-420
In Commercial Distribution

  • 05415334034303 ()
K9350202X

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034297

MNA-440 DEC HDMI V2 INC SFP+ US
Barco NV
MNA-440
In Commercial Distribution

  • 05415334034297 ()
K9350204B

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034280

MNA-440 DEC HDMI V2 INC SFP+ XX
Barco NV
MNA-440
In Commercial Distribution

  • 05415334034280 ()
K9350204X

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034273

MNA-440 DEC HDMI V2 INC SFP+ CN
Barco NV
MNA-440
In Commercial Distribution

  • 05415334034273 ()
K9350204I

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334034259

MNA-440 DEC HDMI V2 INC SFP+ EU
Barco NV
MNA-440
In Commercial Distribution

  • 05415334034259 ()
K9350204F

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334033337

NEXXIS SYSTEM X670 CM US V3
Barco NV
Nexxis system
In Commercial Distribution

  • 05415334033337 ()
K9605028

  • Operating room audiovisual data/device management system

Nexxis OR - 05415334033047

NEXXIS SYSTEM X620 CM V3
Barco NV
Nexxis
In Commercial Distribution

  • 05415334033047 ()
K9605026

  • Operating room audiovisual data/device management system

REGIUS MODEL 110HQ - 04560141936737

No Description
KONICA MINOLTA, INC.
A5RF
In Commercial Distribution

  • 04560141936737 ()


  • Computed radiography digital imaging scanner
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