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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Digital Radiographic System
Imaging Dynamics Company Ltd
1590 X4C
In Commercial Distribution

  • 00823073031012 ()

  • Stand and Detector Head
  • Weight: 267 Kilogram
  • Height: 207 Centimeter


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1590 X3C
In Commercial Distribution

  • 00823073021020 ()

  • Stand and Detector Head
  • Weight: 267 Kilogram
  • Height: 207 Centimeter


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1500 X4C
In Commercial Distribution

  • 00823073021013 ()

  • Stand and Detector Head
  • Weight: 260 Kilogram
  • Height: 212 Centimeter


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1100 X3C
In Commercial Distribution

  • 00823073011021 ()

  • Weight of Table and Detector Head
  • Table Dimensions
  • Height: 93 Centimeter
  • Width: 85.3 Centimeter
  • Length: 240 Centimeter
  • Weight: 233 Kilogram


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1100 X4C
In Commercial Distribution

  • 00823073011014 ()

  • Height: 93 Centimeter
  • Width: 85.3 Centimeter
  • Weight of Table and Detector Head
  • Table Dimensions
  • Length: 240 Centimeter
  • Weight: 233 Kilogram


  • Stationary basic diagnostic x-ray system, digital
Digital Radiographic System
Imaging Dynamics Company Ltd
1800 X4C
In Commercial Distribution

  • 00823073061019 ()

  • Height: 244 Centimeter
  • Stand and Detector Head
  • Weight: 875 Kilogram


  • Stationary basic diagnostic x-ray system, digital
The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost
Not in Commercial Distribution

  • 00884838064751 ()
712214

  • Stationary basic diagnostic x-ray system, digital
The DuraDiagnost Compact is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
Philips Healthcare (Suzhou) Co., Ltd.
DuraDiagnost Compact
Not in Commercial Distribution

  • 00884838064737 ()
712213

  • Stationary basic diagnostic x-ray system, digital
Antiseptic Skin Cleansing Kit with 2% Chlorhexidine Gluconate (CHG)
SAGE PRODUCTS, LLC
9101
In Commercial Distribution

  • 50618029850596 ()
  • 00618029850591 ()
9101

  • Dry medical towel/wipe, single-use
  • Skin cleaning wipe
FRAXEL FTX CONSOLE, NEXT GENERATION
SOLTA MEDICAL
MCSYSFTX
In Commercial Distribution

  • 00816995027805 ()
MCSYSFTX

  • Dermatological laser beam guiding handpiece
  • Dermatological solid-state laser system
REFURBISHED FRAXEL FTX CONSOLE, NEXT GENERATION
SOLTA MEDICAL
MCSYSFTX-R
In Commercial Distribution

  • 00816995027799 ()
MCSYSFTX-R

  • Dermatological solid-state laser system
  • Dermatological laser beam guiding handpiece
Iowa State Fixation Forceps, Flat Handle With Polished Finish, Straight Shafts, 1 X 2 Teeth, And Overall Length Of 3 3/8" (86mm)
Med Saver, Inc.
5-2835
In Commercial Distribution

  • 00194613006624 ()


  • Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable
This mobile digital radiographic system is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
SEDECAL
SM-50HF-B-D-C
In Commercial Distribution

  • 08436046001527 ()


  • Mobile basic diagnostic x-ray system, digital
No Description
NICAL SPA
NFP Digital detector
In Commercial Distribution

  • 08056600520051 ()
NFPMD4335

  • Computed radiography digital imaging scanner
No Description
NICAL SPA
NFP Digital detector
In Commercial Distribution

  • 08056600520044 ()
NF3024C00

  • Computed radiography digital imaging scanner
No Description
THALES AVS FRANCE SAS
63111976
In Commercial Distribution

  • 03701440100035 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
X-ray, Fluoroscopic, image-intensified system
Rayence Co., Ltd.
0909FCC
In Commercial Distribution

  • 08800018602195 ()


  • Indirect flat panel x-ray detector
X-ray, Fluoroscopic, image-intensified system
Rayence Co., Ltd.
0909FCC-HS
In Commercial Distribution

  • 08800018602201 ()


  • Indirect flat panel x-ray detector
The 0909FCB flat panel detector employs a CsI:Tl scintillator for X-ray-to-light converter. Column-structurized CsI:Tl scintillator have high resolution performance due to much less light blurring, and is thus available for a longer period of time. CMOS active pixel detector makes extremely low noise level and highly sensitive performance. Due to seamless one chip CMOS, there is no data missing or artifacts. The high physical and functional performance of 0909FCB gives competitive image quality. The RAW files can be further processed as DICOM compatible image files by separate console SW for a radiographic diagnosis and analysis.
Rayence Co., Ltd.
0909FCB
In Commercial Distribution

  • 08800018600900 ()


  • Indirect flat panel x-ray detector
No Description
CANON INC.
CSX-30
In Commercial Distribution

  • 04549292075175 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
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