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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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Imaging device with FORS technology intended to aid the positioning and navigation of a connected AltaTrack Guidewire and optionally a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of the connected AltaTrack Guidewire, and of an endovascular catheter, when combined with an AltaTrack 3D Hub.
Philips Medical Systems Nederland B.V.
AltaTrack equipment
Not in Commercial Distribution

  • 00884838099340 ()
4322 070 2535 X

  • Diagnostic x-ray digital imaging system workstation application software
Disposable acupuncture needle, 0.25mm × 40mm (#32), with spring handle and guide tube. Sterile, single-use. Packaged 10 needles per blister, 100 blisters per box (1000 needles total).
TCMZone, LLC
TIK-0.25mm x 40mm
In Commercial Distribution

  • 00860014142499 ()
  • 00860014142451 ()
TIK-0.25mm x 40mm (#32)

  • Acupuncture needle, single-use
Disposable acupuncture needle, 0.22mm × 40mm (#34), with spring handle and guide tube. Sterile, single-use. Packaged 10 needles per blister, 100 blisters per box (1000 needles total).
TCMZone, LLC
TIK-0.22mm x 40mm
In Commercial Distribution

  • 00860014142482 ()
  • 00860014142444 ()
TIK-0.22mm x 40mm (#34)

  • Acupuncture needle, single-use
Disposable acupuncture needle, 0.20mm × 40mm (#36), with spring handle and guide tube. Sterile, single-use. Packaged 10 needles per blister, 100 blisters per box (1000 needles total).
TCMZone, LLC
T1K-0.20mm x 40mm
In Commercial Distribution

  • 00860014142475 ()
  • 00860014142437 ()
T1K-0.20mm x 40mm (#36)

  • Acupuncture needle, single-use
Disposable acupuncture needle, 0.20mm × 30mm (#36), with spring handle and guide tube. Sterile, single-use. Packaged 10 needles per blister, 100 blisters per box (1000 needles total).
TCMZone, LLC
T1K-0.20mm x 30mm
In Commercial Distribution

  • 00860014142475 ()
  • 00860014142413 ()
T1K-0.20mm x 30mm (#36)

  • Acupuncture needle, single-use
No Description
Wuxi Wemade Healthcare Products Co., Ltd.
5CM X 450CM
In Commercial Distribution

  • 06938799200131 ()


  • Skin treatment/dressing-supportive limb/finger bandage, single-use
The MEBO Wound Dressing is a C060 gamma-adiation sterilized dressing consisting of sesame oi, beeswax and fabric dressing, which provides a moist environment for optimal wound healing.
Mebo Life Science Inc.
40mm x 60mm
In Commercial Distribution

  • 00860005367542 ()


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
The MEBO Wound Dressing is a C060 gamma-adiation sterilized dressing consisting of sesame oi, beeswax and fabric dressing, which provides a moist environment for optimal wound healing
Mebo Life Science Inc.
60mm x 120mm
In Commercial Distribution

  • 00860005367535 ()


  • Wound-nonadherent dressing, absorbent, non-antimicrobial
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
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
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