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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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ProOcular Daily Disposable Contact Lens Power -5
CARLSBAD TECHNOLOGY INC.
-5
Not in Commercial Distribution

  • 40816816880532 ()
  • 30816816880535 ()
  • 10816816880531 ()
  • 00816816880534 ()


  • Soft corrective contact lens, daily-disposable
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
Uni Tibial Tray Size 5
SIGNAL MEDICAL CORPORATION
5
In Commercial Distribution

  • B046WZ110150 ()
WZ-1-1015

  • Coated unicondylar knee tibia prosthesis
Uni Femoral Knee Size 5
SIGNAL MEDICAL CORPORATION
5
In Commercial Distribution

  • B046WZ110050 ()
WZ-1-1005

  • Coated knee femur prosthesis
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
External support for vascular access arteriovenous fistulas
LAMINATE MEDICAL TECHNOLOGIES LTD
5
In Commercial Distribution

  • 07290016063356 ()
FG0035

  • Arteriovenous fistula extraluminal mesh-sleeve
No Description
Chemoment Materials Co., Ltd.
5
In Commercial Distribution

  • 06976009585555 ()


  • Silicone dental impression material
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