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

  • 04053755200238 ()
F-000.22.105

  • Laryngoscope blade, reusable
SE CUTTING INSTRUMENT NO. 5
NORDENT MANUFACTURING INC
5
In Commercial Distribution

  • 00840018633681 ()


  • Margin finishing dental file/rasp, reusable
No Description
QIAGEN GmbH
5
In Commercial Distribution

  • 04053228045809 ()
62724

  • Nucleic acid extraction/isolation kit IVD
No Description
icometrix NV
5
In Commercial Distribution

  • B621ICOBRAIN50 ()


  • Radiology DICOM image processing application software
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
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
No Description
Everly Health, Inc.
5
In Commercial Distribution

  • G7324001 ()


  • Urine specimen collection kit IVD
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
Tinted Glow Powder
JBC and Company
5
In Commercial Distribution

  • D85105 ()
5-2

  • Dental appliance fabrication material, resin
5" Alligator Rongeur
MEDISURGE LLC
5"
In Commercial Distribution

  • G611BIO110410 ()
BIO-1-1041

  • Orthopaedic joint/limb rongeur
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