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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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The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GR40CW
In Commercial Distribution

  • 08806088773797 ()


  • Diagnostic x-ray digital imaging conversion system
The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GR40CW
In Commercial Distribution

  • 08806088538440 ()


  • Diagnostic x-ray digital imaging conversion system
The GR40CW and GR40CWC Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GR40CWC
In Commercial Distribution

  • 08801643676568 ()


  • Diagnostic x-ray digital imaging conversion system
GRI-FILL is a pharmacy compounding device (PCD) and as such is an electromechanical device controlled by software intended to deliver a specified concentration or proportion of ingredients different from the initial solutions.
LABORATORIOS GRIFOLS SA
-
In Commercial Distribution

  • 08426314948258 ()


  • Pharmaceutical fluid-dispensing system
A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FINK ENGINEERING PTY LTD
TL20
In Commercial Distribution

  • B718TL20287CM090 ()
TL20287CM09

  • Hyperbaric chamber, stationary
A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FINK ENGINEERING PTY LTD
TL20
In Commercial Distribution

  • B718TL20287CM060 ()
TL20287CM06

  • Hyperbaric chamber, stationary
A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FINK ENGINEERING PTY LTD
DL8
In Commercial Distribution

  • B718DL82130 ()
DL8213

  • Hyperbaric chamber, stationary
A mains electricity (AC-powered) hard-shelled vessel (e.g., metal, acrylic) in which a patient is placed to receive hyperbaric oxygen therapy (HBOT), the medical use of oxygen (O2) at a higher than atmospheric pressure. The device increases environmental O2 pressure above normal to promote movement of O2 into a patient's tissues. It typically includes an airlock(s) for patient/object entry, view ports, air valves, and a control panel. It is used to treat disorders that typically include decompression sickness, carbon monoxide poisoning, air/gas embolism, necrotizing tissue infections, and various injuries/wounds; it can also be used to study effects of pressure and decompression.
FINK ENGINEERING PTY LTD
DL8
In Commercial Distribution

  • B718DL82030 ()
DL8203

  • Hyperbaric chamber, stationary
THL 4143C CsI High Resolution Digital Flat Panel Detector-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN261
In Commercial Distribution

  • 00817100020308 ()


  • Diagnostic x-ray digital imaging conversion system
THL 3543EZ CsI Digital Wireless Flat Panel Detector-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN280
In Commercial Distribution

  • 00817100020285 ()


  • Diagnostic x-ray digital imaging conversion system
THL 4343 CsI Digital Flat Panel Detector-R
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN260
In Commercial Distribution

  • 00817100020261 ()


  • Diagnostic x-ray digital imaging conversion system
IR 14X17 Portable GOS Flat Panel Detector without USB (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN241
In Commercial Distribution

  • 00817100020247 ()


  • Diagnostic x-ray digital imaging conversion system
IR 14X17 Portable GOS Flat Panel Detector (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN240
In Commercial Distribution

  • 00817100020230 ()


  • Diagnostic x-ray digital imaging conversion system
IR 17X17 GOS Fixed Flat Panel Detector (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN221
In Commercial Distribution

  • 00817100020223 ()


  • Diagnostic x-ray digital imaging conversion system
IR 17X17 CsI Fixed Flat Panel Detector (-R or -L)
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
PAN220
In Commercial Distribution

  • 00817100020216 ()


  • Diagnostic x-ray digital imaging conversion system
PLUNGER FOR UNIVERSAL DISPENSER
Gc America Inc.
152081
In Commercial Distribution

  • 10386040012393 ()
152081

  • Pharmaceutical fluid-dispensing system
Mixing Tips 48 x MIXING TIPS INJECTION NDS PINK
Gc America Inc.
153148
In Commercial Distribution

  • 00386040006180 ()
  • 10386040006187 ()
153148

  • Pharmaceutical fluid-dispensing system
Mixing Tips 48 x MIXING TIPS HEAVY NDS PURPLE
Gc America Inc.
153048
In Commercial Distribution

  • 00386040006173 ()
  • 10386040006170 ()
153048

  • Pharmaceutical fluid-dispensing system
Mixing Tips 12 x MIXING TIPS AQUA TYPE 2L NDS
Gc America Inc.
153012
In Commercial Distribution

  • 00386040006166 ()
  • 10386040006163 ()
153012

  • Pharmaceutical fluid-dispensing system
GC CARTRIDGE DISPENSER II Plunger Conversion Kit, 75mL
Gc America Inc.
152171
In Commercial Distribution

  • 10386040006156 ()
152171

  • Pharmaceutical fluid-dispensing system
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