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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GC CARTRIDGE DISPENSER II Plunger Conversion Kit, 75mL
Gc America Inc.
152171
In Commercial Distribution

  • D6581521711 ()
152171

  • Pharmaceutical fluid-dispensing system
GC CARTRIDGE DISPENSER II Plunger, 48mL
Gc America Inc.
152161
In Commercial Distribution

  • D6581521611 ()
152161

  • Pharmaceutical fluid-dispensing system
GC CARTRIDGE DISPENSER II 75mL
Gc America Inc.
152102
In Commercial Distribution

  • D6581521021 ()
152102

  • Pharmaceutical fluid-dispensing system
GC CARTRIDGE DISPENSER II 48mL
Gc America Inc.
152101
In Commercial Distribution

  • D6581521011 ()
152101

  • Pharmaceutical fluid-dispensing system
PLUNGER FOR UNIVERSAL DISPENSER
Gc America Inc.
152081
In Commercial Distribution

  • D6581520811 ()
152081

  • Pharmaceutical fluid-dispensing system
100 INTRAORAL TIPS UNIVERSAL/NDS
Gc America Inc.
150100
In Commercial Distribution

  • D6581501001 ()
  • D6581501000 ()
150100

  • Pharmaceutical fluid-dispensing system
COE® ADHESIVE Bulk Bottles (Set of 12), 13mL
Gc America Inc.
133912
In Commercial Distribution

  • D6581339121 ()
133912

  • Pharmaceutical fluid-dispensing system
COE® ADHESIVE BOTTLE ONLY, 13mL
Gc America Inc.
133911
In Commercial Distribution

  • D6581339111 ()
133911

  • Pharmaceutical fluid-dispensing system
The Althea 4200 chamber system is a monoplace hyperbaric chamber outfitted with a large round door. The chamber is pressurized with air, and oxygen is delivered via hood or mask. Pressure and depressurization controls can either be operated manually or automatically. The chamber includes an intercom system that allows two-way communication between the operator and the patient. The chamber is designed to fit through a commonly available 48” doorway.
PCCI HYPERBARIC SYSTEMS
Althea 4200
In Commercial Distribution

  • 00850011262016 ()


  • Hyperbaric chamber, stationary
Hyperbaric Chamber System: Model 7806D Medical Air Lock, 78" diameter. Dual lock, rated for 6 persons in Main Lock and 2 persons in Entry Lock.
PCCI HYPERBARIC SYSTEMS
7806D Medical Air Lock
In Commercial Distribution

  • 00850011262009 ()


  • Hyperbaric chamber, stationary
The product is used to supply power for SE.
FUJIFILM CORPORATION
DR1280 SE BATTERY E
In Commercial Distribution

  • 04547410530650 ()


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1280PB supplies the power to the flat panel sensor connected by a medical professional and establishes intercommunication between the flat panel sensor and the image processing unit connected beforehand. Also, it transfers images acquired by the flat panel sensor to the image processing unit.
FUJIFILM CORPORATION
DR-ID 1280 PB E
In Commercial Distribution

  • 04547410530643 ()


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1280MP supplies the power to the flat panel sensor connected by a medical professional and establishes intercommunication between the flat panel sensor and the image processing unit connected beforehand. Also, it transfers images acquired by the flat panel sensor to the image processing unit.
FUJIFILM CORPORATION
DR-ID 1280 MP E
In Commercial Distribution

  • 04547410530636 ()


  • Diagnostic x-ray digital imaging conversion system
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 E
In Commercial Distribution

  • 04547410530629 ()


  • Diagnostic x-ray digital imaging conversion system
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 E
In Commercial Distribution

  • 04547410530612 ()


  • Diagnostic x-ray digital imaging conversion system
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 E
In Commercial Distribution

  • 04547410530605 ()


  • Diagnostic x-ray digital imaging conversion system
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 E
In Commercial Distribution

  • 04547410530599 ()


  • Diagnostic x-ray digital imaging conversion system
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 E
In Commercial Distribution

  • 04547410530582 ()


  • Diagnostic x-ray digital imaging conversion system
A hardware for installing software.
FUJIFILM CORPORATION
DR-ID1200 GPU EX-M1 MDR E
In Commercial Distribution

  • 04547410448214 ()


  • Diagnostic x-ray digital imaging conversion system
An access point used for wireless communication between the flat panel sensor and the image processing unit.
FUJIFILM CORPORATION
DR-ID 1200 AP KIT MDR E
In Commercial Distribution

  • 04547410438352 ()


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1213 SE W SDK E
In Commercial Distribution

  • 04547410436723 ()

  • 328x268x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1212 SE W SDK E
In Commercial Distribution

  • 04547410436716 ()

  • 460x460x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1211 SE W SDK E
In Commercial Distribution

  • 04547410436709 ()

  • 460x384x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1202 SE W SDK E
In Commercial Distribution

  • 04547410436693 ()

  • 460x460x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1201 SE W SDK E
In Commercial Distribution

  • 04547410436686 ()

  • 460x384x15mm


  • Diagnostic x-ray digital imaging conversion system
The FDR SE Console is a workstation intended to associate digital (for DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.
FUJIFILM CORPORATION
DR-ID330CL
In Commercial Distribution

  • 04547410414530 ()


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1213 SE A E
In Commercial Distribution

  • 04547410335286 ()

  • 328x268x15mm


  • Diagnostic x-ray digital imaging conversion system
A battery charger for the battery pack.
FUJIFILM CORPORATION
DR1200 SE BATTERY CHARGER A E
In Commercial Distribution

  • 04547410333374 ()


  • Diagnostic x-ray digital imaging conversion system
A device supplying power to the flat panel sensor and connecting between the flat panel sensor and the control cabinet.
FUJIFILM CORPORATION
DR-ID 1200 PB E
In Commercial Distribution

  • 04547410319385 ()


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1212 SE A E
In Commercial Distribution

  • 04547410309324 ()

  • 460x460x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1211 SE A E
In Commercial Distribution

  • 04547410309294 ()

  • 460x384x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1202 SE A E
In Commercial Distribution

  • 04547410309249 ()

  • 460x460x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1213 SE W E
In Commercial Distribution

  • 04547410308549 ()

  • 328x268x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1212 SE W E
In Commercial Distribution

  • 04547410308532 ()

  • 460x460x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1211 SE W E
In Commercial Distribution

  • 04547410308525 ()

  • 460x384x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1202 SE W E
In Commercial Distribution

  • 04547410308518 ()

  • 460x460x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1201 SE W E
In Commercial Distribution

  • 04547410308501 ()

  • 460x384x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1201 SE A E
In Commercial Distribution

  • 04547410308211 ()

  • 460x384x15mm


  • Diagnostic x-ray digital imaging conversion system
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
FUJIFILM CORPORATION
DR-ID 1213 SE E
In Commercial Distribution

  • 04547410305067 ()

  • 328x268x15mm


  • Diagnostic x-ray digital imaging conversion system
A cable used for connecting the flat panel sensor and the optional access point. This cable is used for wired communication if wireless communication is not available.
FUJIFILM CORPORATION
DR-ID 1200 AP-SE CBL E
In Commercial Distribution

  • 04547410290899 ()


  • Diagnostic x-ray digital imaging conversion system
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