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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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eRAD PACS v9
Erad, Inc.
9
In Commercial Distribution

  • 00866994000255 ()


  • Radiological PACS software
No Description
Ad-Tech Medical Instrument Corporation
9
In Commercial Distribution

  • 00841823109705 ()
BF08R-SP61X-0C3

  • 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 twin pack sharps disposal ship back system (Includes two 2 gallon sharps container, box, bag, zip tie).
PUREWAY COMPLIANCE
9
In Commercial Distribution

  • 10853022008069 ()
  • 00853022008062 ()

  • Total Volume: 2.0 Gallon
40022

  • Sharps container
SE CUTTING INSTRUMENT #9
NORDENT MANUFACTURING INC
9
In Commercial Distribution

  • 00840018633728 ()


  • Margin finishing dental file/rasp, reusable
ProOcular Daily Disposable Contact Lens Power -9
CARLSBAD TECHNOLOGY INC.
-9
Not in Commercial Distribution

  • 40816816880631 ()
  • 30816816880634 ()
  • 10816816880630 ()
  • 00816816880633 ()


  • Soft corrective contact lens, daily-disposable
Dental implant planning software
Dental Wings GmbH
9
Not in Commercial Distribution

  • D835CDX202 ()
  • D835CDX1 ()
  • D835CDX201 ()
  • D835CDX200 ()


  • Diagnostic x-ray digital imaging system workstation
Dental CADCAM Software
Dental Wings Inc
9
In Commercial Distribution

  • D840DWOSCAD1 ()


  • Dental milling system, CAD/CAM, laboratory
9" Alligator Rongeur
MEDISURGE LLC
9"
In Commercial Distribution

  • G611BIO110430 ()
BIO-1-1043

  • Orthopaedic joint/limb rongeur
9" Alligator Rongeur
SIGNAL MEDICAL CORPORATION
9"
In Commercial Distribution

  • B046BIO110430 ()
BIO-1-1043

  • Orthopaedic joint/limb rongeur
PACS Device
Les Systèmes Médicaux Intelerad Incorporée
9
In Commercial Distribution

  • B228INTELEHEART0 ()


  • Radiological PACS software
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