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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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The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal. The containers are designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture. In summary, all PureWay® Sharps Collector containers are blow molded using High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure. 2 gallon sharps disposal ship back system (Includes one 2 gallon container, box, bag, zip tie).
PUREWAY COMPLIANCE
5
In Commercial Distribution

  • 10853022008021 ()

  • Total Volume: 2.0 Gallon
40002

  • Sharps container
5" Alligator Rongeur
SIGNAL MEDICAL CORPORATION
5"
In Commercial Distribution

  • B046BIO110410 ()
BIO-1-1041

  • Orthopaedic joint/limb rongeur
No Description
Ortoma AB (Publ)
5
In Commercial Distribution

  • 07350137520029 ()
20-100

  • Electromagnetic/optical surgical navigation device tracking system
No Description
Ortoma AB (Publ)
5
In Commercial Distribution

  • 07350137520005 ()
20-101

  • Surgical planning/navigation-enhancement system
A software application to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data, Including functions for viewing, communication, printing, recording/ disc burning and/or image manipulation.
RADMEDIX, LLC
5
In Commercial Distribution

  • 00810035220379 ()


  • Radiology DICOM image processing application software
No Description
Chemoment Materials Co., Ltd.
5
In Commercial Distribution

  • 06976009585555 ()


  • Silicone dental impression material
KIT, SMALL, "B". Includes: 112 - DISC, CIRCULAR, 7” DIAMETER x 1.5” (00810050241175), 114 - RECTANGLE, 2” x 7.5” x 9.5” (00810050241649), 116 - WEDGE, 3” x 4” x 7” (10810050242964), 117 - WEDGE, 2.5” x 7” x 10” (10810050242933), 118 - WEDGE, 7” x 7” x 7” (00810050242387), 121 - BLOCK, OBLIQUE FINGER, 3.13” x 5.5” x 5” (00810050241052)
DOMICO MED-DEVICE, LLC
5
In Commercial Distribution

  • 00810050243308 ()


  • Multifunction body cushion
  • Radiological general body-part positioner
Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
5
In Commercial Distribution

  • B185FS059370 ()


  • Psychophysiological biofeedback system
No Description
MATH RESOLUTIONS, LLC
5
In Commercial Distribution

  • B229DC051 ()


  • Radiation therapy software
No Description
Mobilehelp, LLC
5
In Commercial Distribution

  • 00817644020079 ()


  • Home healthcare information system application software
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