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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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Symmetry Shea - 00887482040355

Symmetry® Hook, Shea Stapes, 20° Angle, 0.5 mm
SYMMETRY SURGICAL INC.
62-0445
In Commercial Distribution

  • 00887482040355 ()

  • Length: 0.5 Inch
62-0445

  • Robotic surgical navigation system application software

Cenova - 15420045515369

No Description
Hologic, Inc.
Cenova Server
In Commercial Distribution

  • 15420045515369 ()


  • Radiology DICOM image processing application software

Cenova - 15420045515345

No Description
Hologic, Inc.
Cenova Server
In Commercial Distribution

  • 15420045515345 ()


  • Radiology DICOM image processing application software

MOR® Surgical Kit - No Tools - 00841549118432

Intended to be used during implant surgical procedures to drill, bone tap or countersink bone or tissue in the mandible or maxilla of patient. This kit contains no surgical tools.
STERNGOLD DENTAL LLC
905252
In Commercial Distribution

  • 00841549118432 ()


  • Dental/maxillofacial surgical procedure kit, medicated, reusable

Evolution4K - 00817613021137

LCD touch screen recording system with HDMI loop through. Software version 1.7.28
Nds Surgical Imaging LLC
Evo4K130
Not in Commercial Distribution

  • 00817613021137 ()


  • Endoscopic video image processing unit

Evolution4K - 00817613021090

LCD touch screen recording system with HDMI loop through. Software version 1.7.25
Nds Surgical Imaging LLC
Evo4K130
In Commercial Distribution

  • 00817613021090 ()


  • Endoscopic video image processing unit

plusoptiX 16 - 04260184514212

The plusoptiX 16 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
S16
In Commercial Distribution

  • 04260184514212 ()
  • 04260184514229 ()
S16

  • External ocular measurement camera

plusoptiX 16 - 04260184514113

The plusoptiX 16 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
A16
In Commercial Distribution

  • 04260184514113 ()
  • 04260184514120 ()
A16

  • External ocular measurement camera

plusoptiX 12 - 04260184513215

The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
S12R
In Commercial Distribution

  • 04260184513215 ()
  • 04260184513222 ()
S12R

  • External ocular measurement camera

plusoptiX 12 - 04260184513116

The plusoptiX 12 is a hand held autorefractor and measures refractive data, pupil size, pupil distance and gaze deviation in real time. Both eyes are measured at the same time (binocular) at a distance of one meter (3.3 ft) to the patient eyes.
Plusoptix GmbH
A12R
In Commercial Distribution

  • 04260184513116 ()
  • 04260184513123 ()
A12R

  • External ocular measurement camera
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