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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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No Description
CITIEFFE SRL
Eba One static cephalic screw ø10.5mm L80mm
In Commercial Distribution

  • 08059386741986 ()
EBA-586080

  • Orthopaedic bone screw (non-sliding)
No Description
CITIEFFE SRL
Eba One static cephalic screw ø10.5mm L75mm
In Commercial Distribution

  • 08059386741979 ()
EBA-586075

  • Orthopaedic bone screw (non-sliding)
No Description
CITIEFFE SRL
Eba One static cephalic screw ø10.5mm L70mm
In Commercial Distribution

  • 08059386741962 ()
EBA-586070

  • Orthopaedic bone screw (non-sliding)
No Description
CITIEFFE SRL
Nails ruler kit with wire ø2,5x800mm
In Commercial Distribution

  • 08059386741108 ()
EBA-5233

  • Medical ruler, single-use
No Description
CITIEFFE SRL
Instrument set tray, 6 empty
In Commercial Distribution

  • 08059386740187 ()
EBA-0245

  • Instrument tray, reusable
CARESCAPE ONE MBZ101 ATO MODEL
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
MBZ101
Not in Commercial Distribution

  • 00840682125901 ()


  • Patient monitoring system module, multifunction
The device is a computer-controlled medical device intended to provide High Intensity Focused Ultrasound (also referred to as HIFU) to ablate prostate tissue. The Focal One system consists of the following main sub-assemblies: Focal One Control Module, Dynamic Focal Probe, and consumable Focalpak. HIFU is a unique process of delivering a large amount of heat energy to a confined space in a highly controlled manner. This energy heats the tissue to ablation levels while minimizing the effect on surrounding structures. The ultrasound energy is delivered via an endorectal probe, which includes an imaging system. The ultrasound waves propagate through the rectal wall and are focused on a portion of the prostate, generating intense heat and causing the ablation of tissue within the targeted area. The process is then repeated in a stepwise fashion to destroy the targeted tissues within the prostate. The apex, sphincter and rectum are preserved while prostate tissues are ablated.Imported diagnostic data can be fused with the real time ultrasound image in order to facilitate the targeting of the ablation volume.
EDAP-TMS FRANCE
TMS 239320
In Commercial Distribution

  • 03661690000052 ()


  • Physical therapy ultrasound system
Sterile 3% Hydrogen Peroxide (Lens Care System)
Ahold U.S.A., Inc.
52
In Commercial Distribution

  • 00041520870902 ()


  • Multi-purpose soft/rigid contact lens solution
Care One Advanced Lancing Device
Ahold U.S.A., Inc.
AT 0270AH
In Commercial Distribution

  • 10041520090956 ()
  • 00041520870490 ()


  • Manual blood lancing device, reusable
No Description
Ahold U.S.A., Inc.
Multi-Purpose Solution (For Soft Contact Lenses)
In Commercial Distribution

  • 00041520869166 ()


  • Multi-purpose soft contact lens solution
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