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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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CAREMIBRAIN - 08437018413188

CareMiBrain is a Positron Emission Tomography system for brain imaging in neurological and oncological applications. It has two main parts: the detection and acquisition system and the Control Unit.
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
FP-0600
In Commercial Distribution

  • 08437018413188 ()

  • Height: 1776 Millimeter
  • Weight: 300 Kilogram
  • Width: 780 Millimeter
  • Depth: 203 Millimeter
  • Length: 2281 Millimeter
FP-0600

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

WPROBE - 08437018413096

GAMMAPRO is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity. GAMMAPRO is comprised of the probe and the software installed in a control unit that is compatible with its use. GAMMAPRO is presented in 4 models: normal (GAMMAPRO STD), High Sensitivity (GAMMAPRO Hi-S), laparoscopic (GAMMAPRO LAP model) and ANGLED (GAMMAPRO ANG).
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
HI-S
In Commercial Distribution

  • 08437018413096 ()

  • Height: 40 Millimeter
  • Length: 255 Millimeter
  • Weight: 182 Gram
  • Width: 40 Millimeter
IC-1160

  • Intraoperative gamma radiation detection system probe, reusable

WPROBE - 08437018413089

GAMMAPRO is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity. GAMMAPRO is comprised of the probe and the software installed in a control unit that is compatible with its use. GAMMAPRO is presented in 4 models: normal (GAMMAPRO STD), High Sensitivity (GAMMAPRO Hi-S), laparoscopic (GAMMAPRO LAP model) and ANGLED (GAMMAPRO ANG).
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
LAP
In Commercial Distribution

  • 08437018413089 ()

  • Length: 514 Millimeter
  • Weight: 182 Gram
  • Width: 40 Millimeter
  • Height: 40 Millimeter
IC-1170

  • Intraoperative gamma radiation detection system probe, reusable

WPROBE - 08437018413072

GAMMAPRO is a wireless ionizing radiation detector probe for use in the medical environment. The instrument is optimized to detect a determined range of gamma radiation energies and maximizes sensitivity and directivity. GAMMAPRO is comprised of the probe and the software installed in a control unit that is compatible with its use. GAMMAPRO is presented in 4 models: normal (GAMMAPRO STD), High Sensitivity (GAMMAPRO Hi-S), laparoscopic (GAMMAPRO LAP model) and ANGLED (GAMMAPRO ANG).
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
STD
In Commercial Distribution

  • 08437018413072 ()

  • Length: 255 Millimeter
  • Weight: 162 Gram
  • Width: 40 Millimeter
  • Height: 40 Millimeter
IC-1150

  • Intraoperative gamma radiation detection system probe, reusable

MAMMI - 08437018413041

MAMMI is a Positron Emission Tomography (PET) system for medical imaging applications and for measuring the distribution of positron-emitting radiodrugs administered to patients to detect breast cancer. The system MAMMI presents two modalities: - Breast PET Mammography System with a single ring detector and a prone examination bed. - Breast PET Mammography System with a double ring detector and a prone examination bed (this record).
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
MAMMI DR
In Commercial Distribution

  • 08437018413041 ()

  • Height: 1480 Millimeter
  • Length: 1430 Micrometer
  • Width: 661 Millimeter
  • Weight: 160 Kilogram
FP-0203

  • PET system

MAMMI - 08437018413034

MAMMI is a Positron Emission Tomography (PET) system for medical imaging applications and for measuring the distribution of positron-emitting radiodrugs administered to patients to detect breast cancer. The system MAMMI presents two modalities: - Breast PET Mammography System with a single ring (SR) detector and a prone examination bed (this record). - Breast PET Mammography System with a double ring (DR) detector and a prone examination bed.
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
MAMMI SR
In Commercial Distribution

  • 08437018413034 ()

  • Weight: 154 Kilogram
  • Height: 1480 Millimeter
  • Length: 1430 Millimeter
  • Width: 661 Millimeter
FP-0202

  • PET system

SENTINELLA - 08437018413027

Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients. Sentinella presents the following modalities: • Sentinella 102 (this record) • Sentinella 102 Horus
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
SENTINELLA 102 HORUS
In Commercial Distribution

  • 08437018413027 ()

  • Height: 185 Centimeter
  • Depth: 77 Centimeter
  • Width: 63 Centimeter
  • Weight: 134 Kilogram
FP-0055

  • Mobile gamma camera system

SENTINELLA - 08437018413010

Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients. Sentinella presents the following modalities: • Sentinella 102 (this record) • Sentinella 102 Horus
GENERAL EQUIPMENT FOR MEDICAL IMAGING SA
SENTINELLA 102
In Commercial Distribution

  • 08437018413010 ()

  • Height: 185 Centimeter
  • Depth: 77 Centimeter
  • Width: 63 Centimeter
  • Weight: 134 Kilogram
FP-0040

  • Mobile gamma camera system

Wi-3 Arm - EAMITRI20700

The Wi-3 Arm is used to fix the outer (white) HAL-RAR sleeve in place to enhance gradual opening of the RAR window when mucopexy is performed, allowing the surgeon, the nurse or any assistant to comfortably hold the system in position. The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary.
AMI Agency for Medical Innovations GmbH
TRI2070
In Commercial Distribution

  • EAMITRI20700 ()
TRI2070

  • Noninvasive vascular ultrasound system

Wi-3 HAL-RAR Unit - EAMITRI20100

Electronic unit for identifying the localised haemorrhoidal arteries by means of acoustic signals. Part of the Wi-3 HAL-RAR System. The Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary.
AMI Agency for Medical Innovations GmbH
TRI2010
Not in Commercial Distribution

  • EAMITRI20100 ()

  • Height: 7 Centimeter
  • Outer Diameter: 23 Centimeter
TRI2010

  • Noninvasive vascular ultrasound system
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