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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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This is a portable digital diagnostic x-ray system 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
SPSLW8
In Commercial Distribution

  • 08436046001879 ()


  • Portable basic diagnostic x-ray system, digital
This is a portable digital diagnostic x-ray system 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
SPSLW4
In Commercial Distribution

  • 08436046001862 ()


  • Portable basic diagnostic x-ray system, digital
Assembled Playbook Unit
ORTHOPEDIATRICS CORP.
NS-4200-0001
In Commercial Distribution

  • 00840194493765 ()
NS-4200-0001

  • Medical image management system
Playbook Assembly
ORTHOPEDIATRICS CORP.
01-4200-0001
Not in Commercial Distribution

  • 00840194471954 ()
01-4200-0001

  • Medical image management system
Playbook Software
ORTHOPEDIATRICS CORP.
PLAYBOOKMDDS
In Commercial Distribution

  • 00840194493871 ()
PLAYBOOKMDDS

  • Medical image management system
The Portable X-ray System (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
Osstem Implant Co., Ltd._Gasan Branch
EXARO
In Commercial Distribution

  • 08800000995014 ()


  • Portable basic diagnostic x-ray system, digital
No Description
REMEDI CO.,LTD.
ES70
In Commercial Distribution

  • 08800060100243 ()


  • Portable basic diagnostic x-ray system, digital
No Description
REMEDI CO.,LTD.
ES70
In Commercial Distribution

  • 08800060100236 ()


  • Portable basic diagnostic x-ray system, digital
No Description
REMEDI CO.,LTD.
REMEX KA6
In Commercial Distribution

  • 08800060100151 ()


  • Portable basic diagnostic x-ray system, digital
No Description
DRAEGER MEDICAL SYSTEMS, INC.
MS26800
In Commercial Distribution

  • 04049098001878 ()


  • Centralized patient monitor
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