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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 non-sterile fabric and foam composite material in the form of a thick band intended to be used to produce a custom-made, figure-of-eight shaped arm sling. Suitable lengths are cut, typically from a roll or a dispenser box, and plastic clips used to fashion two loops, one for round the neck and the other for round a wrist (collar and cuff), to provide support for the arm. It consists of a foam core with a fabric covering and is typically used to immobilize forearm, elbow, humerus or shoulder injuries. This is a single-use device.
Hans Hepp GmbH & Co. KG
92140
In Commercial Distribution

  • 04007418921404 ()


  • Collar and cuff arm sling material
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69462
In Commercial Distribution

  • 00842430114274 ()
69462

  • Wheelchair seat cushion
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
10620
In Commercial Distribution

  • 00842430113321 ()
10620

  • Freestanding patient positioner, reusable
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
246-INFANT
Not in Commercial Distribution

  • 00842430115950 ()
246-INFANT

  • Operating table patient pressure distribution monitoring/regulation system
No Description
ALIMED, INC.
9-503
In Commercial Distribution

  • 00733657244304 ()
2970017446

  • Traction weight
No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
CT-356509420
In Commercial Distribution

  • 00842430103131 ()
CT-356509420

  • Operating table mattress, basic
Made with Tempur-Pedic® Medical materials.
MIZUHO ORTHOPEDIC SYSTEMS, INC.
69461
In Commercial Distribution

  • 00842430102738 ()
69461

  • Wheelchair seat cushion
The Koios DS Breast system is designed to assist qualified interpreting physicians in analyzing breast ultrasound images by providing a system generated categorical output that aligns with or exceeds the sensitivity and specificity of radiologist chosen BI-RADS categorizations using computer vision and machine learning techniques. Koios DS Breast may also be used as an image viewer of multi-modality digital images, including ultrasound and mammography. The software includes tools that allow users to adjust, measure and document images, and output into a structured report.
KOIOS MEDICAL, INC.
2.x
In Commercial Distribution

  • 00860002545707 ()


  • Ultrasound imaging system application software
Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor
Reina Imaging
WDDR[X]
In Commercial Distribution

  • 00860001700176 ()


  • Footstool
  • Flat panel x-ray detector/film cassette weight-bearing protector
SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions of the body, or increase image sharpness for head MRI.
Subtle Medical, Inc.
2.x
In Commercial Distribution

  • 00860000171212 ()


  • Radiology DICOM image processing application software
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