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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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A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C420B
In Commercial Distribution

  • B066C420B1 ()
  • B066C420B5 ()
  • B066C420B4 ()
  • B066C420B3 ()
  • B066C420B2 ()
  • B066C420B0 ()
C420B

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
A plastic device designed to join two or more tubes of a cardiopulmonary bypass system circuit, typically to create an extension or shunt; it may also be used to connect ancillary disposable devices (e.g., temperature probe). It typically has a Y-shape or straight design and is profiled at its ends to create leak-proof connections. This is a single-use device.
NOVOSCI CORP.
C460B
In Commercial Distribution

  • B066C460B1 ()
  • B066C460B5 ()
  • B066C460B3 ()
  • B066C460B2 ()
  • B066C460B0 ()
  • B066C4604 ()
C460B

  • Non-ISO80369-standardized small-bore multichannel connector, single-use
41891 Reusable Gel Pad 3/4'' x 12'' x 25''
XODUS MEDICAL, INC.
41891
In Commercial Distribution

  • 20787551006968 ()
  • 00787551006964 ()
41891

  • Operating table patient pressure distribution pad, reusable
41830 Reusable Gel Chest Roll 20" x 6" x 6"
XODUS MEDICAL, INC.
41830
In Commercial Distribution

  • 20787551006401 ()
  • 00787551006407 ()
41830

  • Operating table patient pressure distribution pad, reusable
No Description
ALIMED, INC.
938553
In Commercial Distribution

  • 00733657265460 ()
2970016580

  • Freestanding patient positioner, reusable
Designed as a patient stabilizer for use when taking a radiograph requiring stitching software. The device provides a stepping platform for the patient and a clear polycarbonate back that allows a radiology technologist to position the device centered to the image receptor, facilitating patient positioning.
Reina Imaging
CSS[X]; SPH-F
In Commercial Distribution

  • 00860001700169 ()


  • Radiological general body-part positioner
No Description
ELECTRO MEDICAL TECHNOLOGIES, LLC
8 x 3
In Commercial Distribution

  • 00861284002629 ()


  • Transcutaneous electrical stimulation electrode, single-use
Cleaner for ultrasonic cleaning of medical devices
ALCONOX INC
.5 x 500
In Commercial Distribution

  • 00660483130597 ()
1305

  • Medical device cleaning agent
The X-ray Imaging System controls the x-ray generation, image processing and patient registration of the McLaren Proton Treatment System. The software product described by this document is considered a sub-system of the MPTS. The software product integrates with the following components of the MPTS system: • X-ray generator & tube assembly • Amorphous silicon flat-panel detector • Electro-mechanical controls of the imaging c-ring to enable system positioning and rotation around the patient The software will permit a radiation technician to set the desired energy levels and field of view. Once set the software can acquire orthogonal or CBCT x-ray images of the region of interest. When images are acquired the software will process them to create viewable images for patient location registration. The patient location registration workflow will locate the treatment isocenter, defined in the patient anatomy, relative to the desired position in the treatment room through which the beam passes. The location of the treatment isocenter is established during treatment planning with 3D planning images (CT simulation images). The patient’s position will be adjusted, if needed, based on a comparison of the current patient location, the defined treatment plan, and previously acquired Digitally Reconstructed Radiographs or CTs. There are two defined methods of registration, 1. Digitally Reconstructed Radiographs (DRRs) from 3D planning images are compared to the 2D images taken during patient setup in order to compare the patient anatomy with the expected location and orientation given by the DRRs. The registration tool is implemented to display both the downloaded DRRs, provided by the treatment planning system, and the display of the new 2D images, acquired by x-ray imaging system. 2. 3D planned volume images are compared to the CBCT volumetric (CTs) images taken during patient setup in order to compare the patient anatomy with the expected location and orientation. The regis
EhmetDx LLC
v.1.x
In Commercial Distribution

  • 00866854000401 ()
n/a

  • CT system application software
Patient Armor Sterilization Pouches 2.75 x 10" - 200/Bx
AMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.
2.75" x 10"
In Commercial Distribution

  • 00858653006005 ()
AMH-210

  • Sterilization packaging, single-use
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