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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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SACRONAIL - 04047844121979

The SACRONAIL system provides a sustained, stable restoration of dorsal pelvic fractures and sacral fractures through its intraosseous location and its direct, bi-iliac symmetric anchorage. The implant consists of a nail of various lengths from135mm to 194mm with a constant diameter of 8mm and 2 locking screws in different lengths. This variation ensures adaptation to the respective anatomy of the patient. The intersections of the screw axes to the implant axis have a distance of 15mm to the respective end face of the nail. This ensures a solid support on the lateral cortex of the Ilia. The angle of the screw axes to the implant axis corresponds to the anatomical conditions and is 70°. The locking screw ensures a stable connection of the components. The tips of the locking screws are rounded to facilitate insertion into the nail while the dorsal ends of locking screws are a hexagon. The caps serve to close the instrument connection of the nail. The implants are made from the Titanium alloy (Ti6Al4V) according to ASTM F 136 / ISO 5832-3, with a Type II anodization according to AMS 2488. There are Instruments which are specific to the implantation of the SACRONAIL device. These include, but are not limited to, the Guide Frame, the Guide Bracket, the Fixation Bracket, various Instrument Guides, various dilators and drills, screwdrivers as well as the specific tools for revision of the device.
SIGNUS Medizintechnik GmbH
Screw pelvic nail
In Commercial Distribution

  • 04047844121979 ()
PBZ0001-8-B

  • Orthopaedic surgical procedure kit, non-medicated, reusable

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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