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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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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

CBYON - 00860008782700

An electrically-powered computer-aided image-guided stereotactic system that typically consist of a mobile cart or carts, computer, 3D tracking system, surgical instruments that can be tracked, and application software for treatment planning and intraoperative navigation in cranial, ENT, and spine surgical procedures. Intraoperative navigation relies on individual or fused CT and MRI scans registered to the patient to allow the surgeon to correlate the position of navigated instruments used in surgery to the 3D images in real-time.
MED-SURGICAL SERVICES, INC.
90000
In Commercial Distribution

  • 00860008782700 ()


  • Multi-purpose stereotactic surgery system

Calibration body EM - B057U1038020

The Calibration body EM is used to calibrate a surgical endoscope which is tracked with Endoscope tracker EM. The location of the Calibration Body EM is referenced relative to the Endoscope tracker EM and allows Navigation Software NOVA AR to compute the optical parameters of the attached surgical endoscope. The Calibration body EM connects to the Hybrid Navigation Unit EM via an integrated cable. The Calibration body EM is provided non-sterile and is intended to be sterilized by the user. The Calibration body EM is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1038020 ()
U1 038 02

  • Electromagnetic surgical navigation device tracking system

DEKA HELIX - 08057017760665

The Helix system consists of: • Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel) • LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of the Helix system with touch-screen technology provided to input commands into the system. • Two wavelengths – CO2 and 1570 nm • Articulated arm • Footswitch • Delivery devices (CO2 non-fractional applicators, Scanner CO2/1570nm fractional applicator)
EL.EN. SPA
M133A1
In Commercial Distribution

  • 08057017760665 ()
M133A1

  • General/multiple surgical diode/carbon dioxide laser system

Adherent Bag - 08720299213616

For the adherent cell culture inside the SCINUS the Adherent Bag is used. This Adherent Bag is intended exclusively for use with the SCINUS. The SCINUS is a closed, controlled bioreactor system for automated cell cultivation. Combined with the Adherent Bag, it allows large-fold cell expansion without passing the cells due to its unique expansion technology. The SCINUS is operated by a controller, which is accessible through an integrated graphical user interface (GUI). The unique combination of the rocker, roller, and Adherent Bag ensures a homogenous environment with minimal levels of shear forces. The roller on top of the rocker enables the expansion of the available culture volume and surface area. The pH and dissolved oxygen (DO) levels are measured by integrated sensors in the Adherent Bag and are controlled with the controller software. The carboxygenator ensures that the set points are maintained within the desired bandwidths. For the culture of adherent cells, the Adherent Bag must be installed in the SCINUS. The Adherent Bag contains the culture bag and the corresponding weldable tubing set. One of the unique features of the Adherent Bag is the gradual expansion of the cell culture volume. The volume can be increased from a minimal volume of 0.1 L to 1.4 L to accommodate the growing cell population.
Scinus Cell Expansion Netherlands B.V.
ADH-01-01
In Commercial Distribution

  • 08720299213616 ()


  • Blood/tissue storage/culture container
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