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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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PACS Scan Software CD
HYLAND LLC
5
In Commercial Distribution

  • 00850677007112 ()


  • Radiography digital imaging scanner
PACS Scan Software
HYLAND LLC
5
In Commercial Distribution

  • 00850677007006 ()


  • Radiography digital imaging scanner
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
SE CUTTING INSTRUMENT NO. 5
NORDENT MANUFACTURING INC
5
In Commercial Distribution

  • 00840018633681 ()


  • Margin finishing dental file/rasp, reusable
CueSee® Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International Normalized Ratio (INR), activated clotting time (ACT) and/or activated partial thromboplastin time (aPTT) measurements on coagulation analyzers in the clinically relevant range. For laboratory and near-patient (point-of-care) testing by healthcare professionals.
Eurotrol B.V.
5
In Commercial Distribution

  • 08718734962816 ()
  • 08718734962762 ()
340.005.005

  • Multiple coagulation factor IVD, control
No Description
Ad-Tech Medical Instrument Corporation
5
In Commercial Distribution

  • 00841823109668 ()
BF10R-SP05X-0BH

  • Depth electrode
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
No Description
Heine Optotechnik GmbH & Co. KG
5
In Commercial Distribution

  • 04053755200238 ()
F-000.22.105

  • Laryngoscope blade, reusable
No Description
Carl Zeiss Meditec AG
5
In Commercial Distribution

  • 04049539070302 ()


  • Operating room audiovisual data/device management system
No Description
QIAGEN GmbH
5
In Commercial Distribution

  • 04053228045809 ()
62724

  • Nucleic acid extraction/isolation kit IVD
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