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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Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK10/75CPUT (1)
In Commercial Distribution

  • 00384401014928 ()

  • Width: 10 Millimeter
  • Length: 75 Millimeter
HGK10/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK14/75CP (1)
In Commercial Distribution

  • 00384401014911 ()

  • Width: 14 Millimeter
  • Length: 75 Millimeter
HGK14/75CP (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK12/75CP (1)
In Commercial Distribution

  • 00384401014904 ()

  • Width: 12 Millimeter
  • Length: 75 Millimeter
HGK12/75CP (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK10/75CP (1)
In Commercial Distribution

  • 00384401014898 ()

  • Width: 10 Millimeter
  • Length: 75 Millimeter
HGK10/75CP (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK20/140P (1)
In Commercial Distribution

  • 00384401014881 ()

  • Width: 20 Millimeter
  • Length: 140 Millimeter
HGK20/140P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK10/140P (1)
In Commercial Distribution

  • 00384401014874 ()

  • Width: 10 Millimeter
  • Length: 140 Millimeter
HGK10/140P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK100/100P (1)
In Commercial Distribution

  • 00384401014867 ()

  • Width: 100 Millimeter
  • Length: 100 Millimeter
HGK100/100P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK75/75P (1)
In Commercial Distribution

  • 00384401014850 ()

  • Width: 75 Millimeter
  • Length: 75 Millimeter
HGK75/75P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK50/50P (1)
In Commercial Distribution

  • 00384401014843 ()

  • Width: 50 Millimeter
  • Length: 50 Millimeter
HGK50/50P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK25/100P (1)
In Commercial Distribution

  • 00384401014836 ()

  • Width: 25 Millimeter
  • Length: 100 Millimeter
HGK25/100P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK25/50P (1)
In Commercial Distribution

  • 00384401014829 ()

  • Width: 25 Millimeter
  • Length: 50 Millimeter
HGK25/50P (1)

  • Cardiovascular patch, animal-derived
Hemacarotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK25/100CPUT (1)
In Commercial Distribution

  • 00384401011248 ()

  • Length: 100 Millimeter
  • Width: 25 Millimeter
HEK25/100CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK10/150CPUT (1)
In Commercial Distribution

  • 00384401011224 ()

  • Length: 150 Millimeter
  • Width: 10 Millimeter
HEK10/150CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK08/120CPUT (1)
In Commercial Distribution

  • 00384401010715 ()

  • Width: 8 Millimeter
  • Length: 120 Millimeter
HEK08/120CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK06/120CPUT (1)
In Commercial Distribution

  • 00384401010708 ()

  • Width: 6 Millimeter
  • Length: 120 Millimeter
HEK06/120CPUT (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK20/140P (1)
In Commercial Distribution

  • 00384401010654 ()

  • Width: 20 Millimeter
  • Length: 140 Millimeter
HEK20/140P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Vascular Patch
INTERVASCULAR SAS
HEK10/140P (1)
In Commercial Distribution

  • 00384401007661 ()

  • Length: 140 Millimeter
  • Width: 10 Millimeter
HEK10/140P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK25/100P (1)
In Commercial Distribution

  • 00384401001591 ()

  • Length: 100 Millimeter
  • Width: 25 Millimeter
HEK25/100P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK50/50P (1)
In Commercial Distribution

  • 00384401001577 ()

  • Length: 50 Millimeter
  • Width: 50 Millimeter
HEK50/50P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK25/50P (1)
In Commercial Distribution

  • 00384401001560 ()

  • Length: 50 Millimeter
  • Width: 25 Millimeter
HEK25/50P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK100/100P (1)
In Commercial Distribution

  • 00384401001522 ()

  • Length: 100 Millimeter
  • Width: 100 Millimeter
HEK100/100P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK75/75P (1)
In Commercial Distribution

  • 00384401001515 ()

  • Length: 75 Millimeter
  • Width: 75 Millimeter
HEK75/75P (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK14/75CPUT (1)
In Commercial Distribution

  • 00384401001508 ()

  • Width: 14 Millimeter
  • Length: 75 Micrometer
HEK14/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK12/75CPUT (1)
In Commercial Distribution

  • 00384401001492 ()

  • Width: 12 Millimeter
  • Length: 75 Millimeter
HEK12/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK10/75CPUT (1)
In Commercial Distribution

  • 00384401001485 ()

  • Width: 10 Millimeter
  • Length: 75 Millimeter
HEK10/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK08/75CPUT (1)
In Commercial Distribution

  • 00384401001478 ()

  • Width: 8 Millimeter
  • Length: 75 Millimeter
HEK08/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK06/75CPUT (1)
In Commercial Distribution

  • 00384401001461 ()

  • Width: 6 Millimeter
  • Length: 75 Millimeter
HEK06/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK14/75CP (1)
In Commercial Distribution

  • 00384401001454 ()

  • Length: 75 Millimeter
  • Width: 14 Millimeter
HEK14/75CP (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK12/75CP (1)
In Commercial Distribution

  • 00384401001447 ()

  • Length: 75 Millimeter
  • Width: 12 Millimeter
HEK12/75CP (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK10/75CP (1)
In Commercial Distribution

  • 00384401001430 ()

  • Length: 75 Millimeter
  • Width: 10 Millimeter
HEK10/75CP (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK06/75CP (1)
In Commercial Distribution

  • 00384401001423 ()

  • Length: 75 Millimeter
  • Width: 6 Millimeter
HEK06/75CP (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK08/75CP (1)
In Commercial Distribution

  • 00384401001416 ()

  • Length: 75 Millimeter
  • Width: 8 Millimeter
HEK08/75CP (1)

  • Cardiovascular patch, animal-derived
Hemashield Woven Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000196270
In Commercial Distribution

  • 00384401018827 ()

  • Length: 15.2 Centimeter
  • Width: 5.1 Centimeter
M002000196270

  • Cardiovascular patch, animal-derived
Hemashield Woven Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000196240
In Commercial Distribution

  • 00384401018810 ()

  • Length: 7.6 Centimeter
  • Width: 5.1 Centimeter
M002000196240

  • Cardiovascular patch, animal-derived
Hemashield Woven Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000196170
In Commercial Distribution

  • 00384401018803 ()

  • Length: 152 Millimeter
  • Width: 25 Millimeter
M002000196170

  • Cardiovascular patch, animal-derived
No Description
Innosys Co., Ltd.
TL0520
In Commercial Distribution

  • 08800015995474 ()


  • Bone graft packing block
No Description
Innosys Co., Ltd.
PL0450
In Commercial Distribution

  • 08800015954730 ()


  • Bone graft packing block
No Description
Innosys Co., Ltd.
PE1020
In Commercial Distribution

  • 08800015953986 ()


  • Bone graft packing block
No Description
Innosys Co., Ltd.
SG0019
In Commercial Distribution

  • 08800015946414 ()


  • Bone graft packing block
Tecapro mt.
Innovasis, Inc.
LS-215
In Commercial Distribution

  • M711LS2150 ()
LS-215

  • Bone graft packing block
Polypropylene
Innovasis, Inc.
LS-459
In Commercial Distribution

  • M711LS4590 ()
LS-459

  • Bone graft packing block
Bone Graft Block Assembly, Al, SST
Innovasis, Inc.
LAA-040
In Commercial Distribution

  • M711LAA0400 ()


  • 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
No Description
Jeil Medical Corporation
111-299
In Commercial Distribution

  • 08806390885331 ()


  • Bone graft packing block
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