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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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Stopper Screw for use with the Piccolo Composite Proximal Femur Nailing System.
CARBOFIX ORTHOPEDICS LTD
Stopper Screw With Pin
In Commercial Distribution

  • 07290117350683 ()
PPF910550

  • Orthopaedic implant aiming arm
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516311790 ()
31179

  • Electronystagmograph
  • Dynamic visual acuity testing system
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516227090 ()
22709

  • Electronystagmograph
  • Dynamic visual acuity testing system
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516222210 ()
22221

  • Electronystagmograph
  • Dynamic visual acuity testing system
All Soft Ureteral Stent - 7F, 26cm with Suture
ALLWIN MEDICAL DEVICES, INC.
7F, 26cm with Suture
In Commercial Distribution

  • 10812261015276 ()
  • 00812261015279 ()
SOT 7/26-S

  • Polymeric ureteral stent
All Soft Ureteral Stent - 6F, 26cm with Suture
ALLWIN MEDICAL DEVICES, INC.
6F, 26cm with Suture
In Commercial Distribution

  • 10812261013753 ()
  • 00812261013756 ()
SOT 6/26-S

  • Polymeric ureteral stent
7F, 22cm with Suture
ALLWIN MEDICAL DEVICES, INC.
7F, 22cm with Suture
In Commercial Distribution

  • 10812261013210 ()
  • 00812261013213 ()
SOT 7/22-S

  • Polymeric ureteral stent
7F, 24cm with Suture
ALLWIN MEDICAL DEVICES, INC.
7F, 24cm with Suture
In Commercial Distribution

  • 10812261010691 ()
  • 00812261010694 ()
SOT 7/24-S

  • Polymeric ureteral stent
No Description
Tianck Medical Co., Ltd.
25cm with three-way stopcock
In Commercial Distribution

  • 06971162810728 ()
044004

  • Invasive blood pressure monitoring tubing set
No Description
Tianck Medical Co., Ltd.
20cm with three-way stopcock
In Commercial Distribution

  • 06971162810711 ()
044003

  • Invasive blood pressure monitoring tubing set
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