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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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Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
IM1110
Not in Commercial Distribution

  • B353IM11103 ()
  • B353IM11102 ()
  • B353IM11101 ()


  • Electrocardiography telemetric monitoring system
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CV1245
Not in Commercial Distribution

  • B353CV12452 ()
  • B353CV12451 ()
  • B353CV12453 ()


  • Electrocardiography telemetric monitoring system
Biosensor Patch - Electrocardiography Telemetric Monitoring Patch
Lifesignals, Inc.
CS1245
Not in Commercial Distribution

  • B353CS124502 ()
  • B353CS124501 ()
  • B353CS124503 ()


  • Electrocardiography telemetric monitoring system
AUTO REF/KERATO/TONOMETER Model TONOREF II is designed to singly perform objective refraction, corneal shape measurement, and non-contact tonometry measurement by incorporating a standard auto ref/keratometer and non-contact tonometer into one unit. The objective refraction function measures spherical powers, cylindrical powers and cylinder axis. The corneal shape measurement function measures the radius of corneal curvature (corneal refractive powers), the direction of the steepest meridian, and the amount of corneal astigmatism. The non-contact tonometry function measures the intraocular pressure without contacting the eye.
NIDEK CO.,LTD.
TONOREF II
In Commercial Distribution

  • 04987669100066 ()


  • Ophthalmic tonometer, line-powered
  • Bench-top keratometer
  • Automated ophthalmic refractometer
The WAM700 is a multifunctional ophthalmic device. The machine is a combination of 5 technologies : - Shack Hartmann technology : to measure both low and high order aberrations of the eye, to measure refraction. - Placido disks : for keratometry and for corneal topography measurement. - Non-contact tonometer. - Scheimpflug image : for anterior chamber analysis (pachymetry, irido corneal angle). - Retro illumination : for detection of opacity. Measurement is fully automatic using image processing software and fully automated motors for centering and focusing. The machine includes a fixation target with automatic fogging for accommodation control.
ESSILOR INTERNATIONAL
WAM700
In Commercial Distribution

  • 03615020000380 ()


  • Corneal topography system analyser
  • Corneal topography system
  • Automated ophthalmic refractometer
  • Bench-top keratometer
  • Ophthalmic tonometer, line-powered
The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S plates. They are available in different diameters and sizes. They exist in different colors for size identification. The unthreaded part provides the system with the mechanism for the bone to slide along this unthreaded body. The design of the thread allows the snap-off screw to be self tapping so that no pre-tap is required when implanting the device .The distal end of the snap-off screw has a smooth tip to protect tissues.
NEWDEAL
117118SND
In Commercial Distribution

  • 10381780047827 ()
  • M248117118SND1 ()

  • 3.0mm diam. x 18mm length
117118SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S plates. They are available in different diameters and sizes. They exist in different colors for size identification. The unthreaded part provides the system with the mechanism for the bone to slide along this unthreaded body. The design of the thread allows the snap-off screw to be self tapping so that no pre-tap is required when implanting the device .The distal end of the snap-off screw has a smooth tip to protect tissues.
NEWDEAL
117118ND
In Commercial Distribution

  • 10381780047810 ()
  • M248117118ND1 ()

  • 3.0mm diam. x 18mm length
117118ND

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S plates. They are available in different diameters and sizes. They exist in different colors for size identification. The unthreaded part provides the system with the mechanism for the bone to slide along this unthreaded body. The design of the thread allows the snap-off screw to be self tapping so that no pre-tap is required when implanting the device .The distal end of the snap-off screw has a smooth tip to protect tissues.
NEWDEAL
117116ND
In Commercial Distribution

  • 10381780047797 ()
  • M248117116ND1 ()

  • 3.0mm diam. x 16mm length
117116ND

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S plates. They are available in different diameters and sizes. They exist in different colors for size identification. The unthreaded part provides the system with the mechanism for the bone to slide along this unthreaded body. The design of the thread allows the snap-off screw to be self tapping so that no pre-tap is required when implanting the device .The distal end of the snap-off screw has a smooth tip to protect tissues.
NEWDEAL
117114ND
In Commercial Distribution

  • 10381780047773 ()
  • M248117114ND1 ()

  • 3.0mm diam. x 14mm length
117114ND

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The titanium alloy SNAP-OFF screws are dedicated for the fixation of the HALLU-C and HALLU-S plates. They are available in different diameters and sizes. They exist in different colors for size identification. The unthreaded part provides the system with the mechanism for the bone to slide along this unthreaded body. The design of the thread allows the snap-off screw to be self tapping so that no pre-tap is required when implanting the device .The distal end of the snap-off screw has a smooth tip to protect tissues.
NEWDEAL
117112SND
In Commercial Distribution

  • 10381780047766 ()
  • M248117112SND1 ()

  • 3.0mm diam. x 12mm length
117112SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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