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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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Standardize is software that provides standardized metadata descriptions of diagnostic medical images. It uses proprietary natural language processing and computer vision algorithms to analyze DICOM images and metadata to identify key attributes of radiological examinations and series.
Enlitic, Inc.
1.0.0
Not in Commercial Distribution

  • 00860002304533 ()


  • Radiology DICOM image processing application software
The Curie product is a software platform that hosts applications related to various healthcare workflows, contains basic functionality such as user access and security, and allows for integrations with other devices such as third-party PACs systems.
Enlitic, Inc.
1.0.0
Not in Commercial Distribution

  • 00860002304526 ()


  • Radiology DICOM image processing application software
Discontinued product code.
DERBY DENTAL LABORATORY, INC
POR
Not in Commercial Distribution

  • 00860002302362 ()


  • Orthodontic retainer
Clear sequential aligner (final retainer) / progressive orthodontic appliance system.
DERBY DENTAL LABORATORY, INC
TSR
Not in Commercial Distribution

  • 00860002302331 ()


  • Orthodontic retainer
Discontinued product code.
DERBY DENTAL LABORATORY, INC
SSR
Not in Commercial Distribution

  • 00860002302324 ()


  • Orthodontic retainer
The dual mode SL5-E system from Mikroscan offers the user two completely separate and distinctly different capabilities in one convenient device. The user selects either the live microscope mode using a fully functional, remotely controlled robotic microscope or a static digital pathology scanner for the creation of whole-slide images. The protection features of the equipment may be impaired if the device is used in a manner not specified by Mikroscan.
MIKROSCAN TECHNOLOGIES, INC.
SL5-E
In Commercial Distribution

  • 00860002275628 ()


  • Microscope slide digital imaging scanner IVD
The L5 system from Mikroscan offers the user a live microscope mode using a fully functional, remotely controlled robotic microscope. The protection features of the equipment may be impaired if the device is used in a manner not specified by Mikroscan.
MIKROSCAN TECHNOLOGIES, INC.
L5
In Commercial Distribution

  • 00860002275611 ()


  • Microscope slide digital imaging scanner IVD
The dual mode SL5 system from Mikroscan offers the user two completely separate and distinctly different capabilities in one convenient device. The user selects either the live microscope mode using a fully functional, remotely controlled robotic microscope or a static digital pathology scanner for the creation of whole-slide images*. The protection features of the equipment may be impaired if the device is used in a manner not specified by Mikroscan. *For Research Use Only. Not for use in diagnostic procedures.
MIKROSCAN TECHNOLOGIES, INC.
SL5
In Commercial Distribution

  • 00860002275604 ()


  • Microscope slide digital imaging scanner IVD
The ebner 502 expanded bone grafter is intended for bone removal and autogenous bone grafting. The instrument is comprised of a stainless steel handle and blade (blade labeled for single use). The blade shaves bone from cortical surfaces producing short convoluted ribbons. While being cut, shavings combine with blood and flow into the handle's head. This graft material, an osseous coagulum, is then delivered with the handle directly to the recipient site, or to a bowl. Blades are standardized so that ebner 500 BLADEs can be used with any ebner 500 HANDLE (501, 502... 5nn). Before the clinician's first case, he should become familiar with the instrument including the mounting and removal of the blade.
MAXILON LABORATORIES INC
10325-02
In Commercial Distribution

  • 00860002195056 ()


  • Bone collection scraper
  • Bone file/rasp, manual, reusable
The ebner 502 expanded bone grafter is intended for bone removal and autogenous bone grafting. The instrument is comprised of a stainless steel handle and blade (blade labeled for single use). The blade shaves bone from cortical surfaces producing short convoluted ribbons. While being cut, shavings combine with blood and flow into the handle's head. This graft material, an osseous coagulum, is then delivered with the handle directly to the recipient site, or to a bowl. Blades are standardized so that ebner 500 BLADEs can be used with any ebner 500 HANDLE (501, 502... 5nn). Before the clinician's first case, he should become familiar with the instrument including the mounting and removal of the blade.
MAXILON LABORATORIES INC
10325-03
In Commercial Distribution

  • 00860002195049 ()


  • Bone collection scraper
  • Bone file/rasp, manual, reusable
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