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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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Size 1
Alliage S/A Indústrias Médico Odontológica
D700 Slim
In Commercial Distribution

  • 07899581340697 ()
16000004373

  • Dental digital imaging sensor, intraoral
Size 2
Alliage S/A Indústrias Médico Odontológica
Saevo Slim
In Commercial Distribution

  • 07899581340284 ()
16000004138

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
Saevo Slim
In Commercial Distribution

  • 07899581340277 ()
16000004137

  • Dental digital imaging sensor, intraoral
Size 2
Alliage S/A Indústrias Médico Odontológica
Eagle S
In Commercial Distribution

  • 07899581340260 ()
16000004136

  • Dental digital imaging sensor, intraoral
Size 1
Alliage S/A Indústrias Médico Odontológica
Eagle S
In Commercial Distribution

  • 07899581340253 ()
16000004135

  • Dental digital imaging sensor, intraoral
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally.
CLEAR GUIDE MEDICAL, INC.
CGCORE24MR
In Commercial Distribution

  • B201CGCORE24MR0 ()
  • B201CGCORE24MR1 ()
CG-CORE24-MR

  • Stereotactic surgery system workstation
  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE24
In Commercial Distribution

  • B201CGCORE240 ()
  • B201CGCORE241 ()
CG-CORE24

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, No Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175801 ()
LES13INND

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 20-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175795 ()
LES13IN02

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
The HarmonyAIR Single Light, with Dual Flat Panel Monitor, 13-inch Drop Tube is a ceiling supported surgical lighting system of one or more E-Series lightheads.
STERIS CORPORATION
E-Series
Not in Commercial Distribution

  • 00724995175788 ()
LES13IN01

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system
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