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No Description
I.C. MEDICAL, INC.
ICM-000-0307
Not in Commercial Distribution
- 00817688021469 ()
- 00817688021452 ()
- Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0014
In Commercial Distribution
- 00817688021445 ()
- 00817688021438 ()
- Surgical plume evacuation system
UNIVERSAL BLUE™ RF Sensor
I.C. MEDICAL, INC.
ICM-000-0599
In Commercial Distribution
- 00817688020363 ()
ICM-000-0599
- Surgical plume evacuation system
Gamma Lewis Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-Lea and anti-Leb activity in serum or plasma. Gamma Lewis Blood Group Substance is a standardized solution of human Lea and Leb blood group substances in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007702
In Commercial Distribution
- 10888234000853 ()
0007702
- Immunoglobulin removal reagent IVD
Gamma P1 Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-P1 activity in serum or plasma. Gamma P1 Blood Group Substance is a standardized solution of avian P1 blood group substance in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007700
In Commercial Distribution
- 10888234000846 ()
0007700
- Immunoglobulin removal reagent IVD
Polypropylene
Innovasis, Inc.
LS-459
In Commercial Distribution
- M711LS4590 ()
LS-459
- Bone graft packing block
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. HEADSTAR is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus), the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests and the Video Head Impulse Test. HEADSTAR is a nystagmography system and is able to record movements of one eye: horizontal, vertical and rotary on option. 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. HEADSTAR 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 VHIT tests and other oculomotor tests.
Instrumentation Difra SA
HeadStar V2.0
In Commercial Distribution
- B516320980 ()
32098
- Electronystagmograph
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
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. HEADSTAR is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus), the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests and the Video Head Impulse Test. HEADSTAR is a nystagmography system and is able to record movements of one eye: horizontal, vertical and rotary on option. 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. HEADSTAR 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 VHIT tests and other oculomotor tests.
Instrumentation Difra SA
HeadStar
In Commercial Distribution
- B516221350 ()
22135
- Electronystagmograph
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.
Instrumentation Difra SA
NysStar II
In Commercial Distribution
- B516221340 ()
22134
- Electronystagmograph
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR I 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 I is able to record all eye movements, as well horizontal, as vertical and even rotary movements on option. The calibration carried out by NYSSTAR I 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.
Instrumentation Difra SA
NysStar I
In Commercial Distribution
- B516221280 ()
22128
- Electronystagmograph
4 Level, 94mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary
stabilization to the anterior spine during the development of cervical spine
fusions (C2-T1) for the following indications: degenerative disc disease (DDD)
(defined as neck pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,
fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,
kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD4-94
In Commercial Distribution
- 111106494 ()
- M364111106FD4940 ()
- Spinal fixation plate, non-bioabsorbable
4 Level, 90mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary
stabilization to the anterior spine during the development of cervical spine
fusions (C2-T1) for the following indications: degenerative disc disease (DDD)
(defined as neck pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,
fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,
kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD4-90
In Commercial Distribution
- 111106490 ()
- M364111106FD4900 ()
- Spinal fixation plate, non-bioabsorbable
4 Level, 78mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary
stabilization to the anterior spine during the development of cervical spine
fusions (C2-T1) for the following indications: degenerative disc disease (DDD)
(defined as neck pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,
fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,
kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD4-78
In Commercial Distribution
- 111106478 ()
- M364111106FD4780 ()
- Spinal fixation plate, non-bioabsorbable
3 Level, 75mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary
stabilization to the anterior spine during the development of cervical spine
fusions (C2-T1) for the following indications: degenerative disc disease (DDD)
(defined as neck pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,
fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,
kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD3-75
In Commercial Distribution
- 111106375 ()
- M364111106FD3750 ()
- Spinal fixation plate, non-bioabsorbable
3 Level, 72mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary
stabilization to the anterior spine during the development of cervical spine
fusions (C2-T1) for the following indications: degenerative disc disease (DDD)
(defined as neck pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,
fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,
kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD3-72
In Commercial Distribution
- 111106372 ()
- M364111106FD3720 ()
- Spinal fixation plate, non-bioabsorbable
3 Level, 69mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary
stabilization to the anterior spine during the development of cervical spine
fusions (C2-T1) for the following indications: degenerative disc disease (DDD)
(defined as neck pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,
fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,
kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD3-69
In Commercial Distribution
- 111106369 ()
- M364111106FD3690 ()
- Spinal fixation plate, non-bioabsorbable
3 Level, 60mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary
stabilization to the anterior spine during the development of cervical spine
fusions (C2-T1) for the following indications: degenerative disc disease (DDD)
(defined as neck pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,
fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,
kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD3-60
In Commercial Distribution
- 111106360 ()
- M364111106FD3600 ()
- Spinal fixation plate, non-bioabsorbable