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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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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
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
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
Bag for retrieving specimen for 5 mm trocars. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery.
AMI Agency for Medical Innovations GmbH
TBI1031
Not in Commercial Distribution

  • EAMITBI10310 ()
  • EAMITBI10311 ()

  • Length: 515 Millimeter
TBI1031

  • Tissue extraction bag
Bag for retrieving specimen for 10mm trocars. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery.
AMI Agency for Medical Innovations GmbH
TBI1021
Not in Commercial Distribution

  • EAMITBI10210 ()
  • EAMITBI10211 ()

  • Length: 485 Millimeter
TBI1021

  • Tissue extraction bag
Mag for retrieving speciment for 10 mm trocars. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery.fsing.
AMI Agency for Medical Innovations GmbH
TBI1011
Not in Commercial Distribution

  • EAMITBI10110 ()
  • EAMITBI10111 ()

  • Length: 515 Millimeter
TBI1011

  • Tissue extraction bag
Bag for retrieving specimen. The various types of retrieval bags belonging to the A.M.I. TissueBag System are intended for safe removal of specimen (appendix, gallbladder, ovaries, fibroid tumours and other tissues, and calculi) during laparoscopic surgery.
AMI Agency for Medical Innovations GmbH
TBI 100
Not in Commercial Distribution

  • EAMITBI1000 ()
  • EAMITBI1001 ()

  • Length: 485 Millimeter
TBI 100

  • Tissue extraction bag
No Description
AMI Agency for Medical Innovations GmbH
RAR2081
In Commercial Distribution

  • EAMIRAR20810 ()
  • EAMIRAR20811 ()

  • Length: 97 Millimeter
  • Outer Diameter: 30 Millimeter
RAR2081

  • Noninvasive vascular ultrasound system
No Description
AMI Agency for Medical Innovations GmbH
RAR 2011
Not in Commercial Distribution

  • EAMIRAR20110 ()
  • EAMIRAR20111 ()
RAR 2011

  • Noninvasive vascular ultrasound system
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgeryto enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for powermorcellation and removal.
AMI Agency for Medical Innovations GmbH
MCS5551
In Commercial Distribution

  • MCS55511 ()
  • EAMIMCS55510 ()
MCS5551

  • Tissue extraction bag
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