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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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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 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
Upper Arm Electronic Blood Pressure Monitor
JUMAX HEALTHCARE LLC
A27
In Commercial Distribution

  • 00860002217208 ()


  • Physiologic-monitoring defibrillation system
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
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
10325-01
In Commercial Distribution

  • 00860002195032 ()


  • 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
10561-05
In Commercial Distribution

  • 00860002195025 ()


  • Bone collection scraper
  • Bone file/rasp, manual, reusable
The Mx-Grafter Bone Grafting System is a manual, self-contained, sterile, single use instrument for the removal, harvest, and grafting of autogenous bone in surgical applications. The instrument is comprised of a plastic handle and stainless steel blade. The blade shaves bone from cortical surfaces producing short convoluted ribbons. While being cut, shavings combine with blood and flow into the handle. This graft material, an osseous coagulum, is then delivered with the handle directly to the recipient site, or to a bowl.
MAXILON LABORATORIES INC
11302
In Commercial Distribution

  • 00860002195001 ()


  • Bone collection scraper
  • Bone file/rasp, manual, reusable
SX-One MicroKnife is rebranded as UltraGuideCTR. UltraGuideCTR is intended to transect the transverse carpal ligament for the treatment of carpal tunnel syndrome. UltraGuideCTR is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.
SONEX HEALTH, INC.
600112-001
In Commercial Distribution

  • 00860002094700 ()
  • 00860002094717 ()
600112-001

  • Hand ligament surgical release instrument
Radiation Shielding Panel, portal/mobile
Rampart Ic, LLC
M1128-RTV01
In Commercial Distribution

  • 00860002090108 ()


  • Radiation shielding panel, portable/mobile
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