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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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
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019530P0
In Commercial Distribution

  • 00384401017974 ()

  • Length: 7.6 Centimeter
  • Width: 2.5 Centimeter
M00202019530P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019579P0
In Commercial Distribution

  • 00384401017950 ()

  • Length: 7.6 Centimeter
  • Width: 0.8 Centimeter
M00202019579P0

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195240
In Commercial Distribution

  • 00384401017929 ()

  • Length: 7.6 Centimeter
  • Width: 5.1 Centimeter
M002000195240

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195090
In Commercial Distribution

  • 00384401017905 ()

  • Length: 7.6 Centimeter
  • Width: 0.8 Centimeter
M002000195090

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195290
In Commercial Distribution

  • 00384401017875 ()

  • Length: 7.6 Centimeter
  • Width: 0.8 Centimeter
M002000195290

  • Cardiovascular patch, animal-derived
Hemashield Knitted Double Velour Cardiovascular Fabric
INTERVASCULAR SAS
M002000195280
In Commercial Distribution

  • 00384401017868 ()

  • Length: 12.0 Centimeter
  • Width: 0.6 Centimeter
M002000195280

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGKTP08/75CPUT (1)
In Commercial Distribution

  • 00384401015208 ()

  • Width: 8 Millimeter
  • Length: 75 Millimeter
HGKTP08/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGKTP08/75CP (1)
In Commercial Distribution

  • 00384401015185 ()

  • Width: 8 Millimeter
  • Length: 75 Millimeter
HGKTP08/75CP (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGKTP08/150CPUT(1)
In Commercial Distribution

  • 00384401015161 ()

  • Width: 8 Millimeter
  • Length: 150 Millimeter
HGKTP08/150CPUT(1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK50/150P (1)
In Commercial Distribution

  • 00384401015130 ()

  • Width: 50 Millimeter
  • Length: 150 Millimeter
HGK50/150P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK50/75P (1)
In Commercial Distribution

  • 00384401015123 ()

  • Width: 50 Millimeter
  • Length: 75 Millimeter
HGK50/75P (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGKTP08/120CPUT(1)
In Commercial Distribution

  • 00384401014980 ()

  • Width: 8 Millimeter
  • Length: 120 Millimeter
HGKTP08/120CPUT(1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGKTP06/120CPUT(1)
In Commercial Distribution

  • 00384401014973 ()

  • Width: 6 Millimeter
  • Length: 120 Millimeter
HGKTP06/120CPUT(1)

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

  • 00384401014942 ()

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

  • Cardiovascular patch, animal-derived
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
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
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
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
The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
EDSEP
Not in Commercial Distribution

  • M272EDSEP1 ()
  • 10381780037088 ()


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D5L25
Not in Commercial Distribution

  • M272AU8D5L251 ()
  • 10381780036531 ()

  • 8 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D10L5
Not in Commercial Distribution

  • M272AU8D10L51 ()
  • 10381780036524 ()

  • 8 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D10L25
Not in Commercial Distribution

  • M272AU8D10L251 ()
  • 10381780036517 ()

  • 8 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6D5L25
Not in Commercial Distribution

  • M272AU6D5L251 ()
  • 10381780036456 ()

  • 6 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6D10L5
Not in Commercial Distribution

  • M272AU6D10L51 ()
  • 10381780036449 ()

  • 6 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6D10L25
Not in Commercial Distribution

  • M272AU6D10L251 ()
  • 10381780036432 ()

  • 6 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D5L25
Not in Commercial Distribution

  • M272AU4D5L251 ()
  • 10381780036326 ()

  • 4 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D10L5
Not in Commercial Distribution

  • M272AU4D10L51 ()
  • 10381780036319 ()

  • 4 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D10L25
Not in Commercial Distribution

  • M272AU4D10L251 ()
  • 10381780036302 ()

  • 4 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU12D5L25
Not in Commercial Distribution

  • M272AU12D5L251 ()
  • 10381780036111 ()

  • 12 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU10D5L25
Not in Commercial Distribution

  • M272AU10D5L251 ()
  • 10381780036104 ()

  • 10 platinum contacts


  • Depth electrode
The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M08
Not in Commercial Distribution

  • M27240M081 ()
  • 10381780034766 ()

  • Insertion needle 64mm Length


  • Depth electrode
This Lumbar Back Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with self modeling and flexible stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively im- mobilizing the lumbar-sacral region. Two rigid abdominal panels are included. these panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of tension settings. INDICATIONS •Lumbago, sciatica and ischialgia. •Lumbar-Sacral pain of other origin and nature. •Disc complaints. •Spondylo-arthrosis. •Osteoporosis related lumbar vertebrae complaints. •Para-vertebral lumbar muscle spasm. •Light trauma of the lumbar-sacral column. Recommended for general back pain and support.
INDACO SRL
505 2XL/3XL
In Commercial Distribution

  • 05391512286408 ()
  • 05391512282820 ()
505

  • Lumbar spine orthosis
This Lumbar Back Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with self modeling and flexible stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively im- mobilizing the lumbar-sacral region. Two rigid abdominal panels are included. these panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of tension settings. INDICATIONS •Lumbago, sciatica and ischialgia. •Lumbar-Sacral pain of other origin and nature. •Disc complaints. •Spondylo-arthrosis. •Osteoporosis related lumbar vertebrae complaints. •Para-vertebral lumbar muscle spasm. •Light trauma of the lumbar-sacral column. Recommended for general back pain and support.
INDACO SRL
505 L/XL
In Commercial Distribution

  • 05391512286392 ()
  • 05391512282813 ()
505

  • Lumbar spine orthosis
This Lumbar Back Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. Made with semi-rigid fabric, it enjoys a structure made with self modeling and flexible stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively im- mobilizing the lumbar-sacral region. Two rigid abdominal panels are included. these panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of tension settings. INDICATIONS •Lumbago, sciatica and ischialgia. •Lumbar-Sacral pain of other origin and nature. •Disc complaints. •Spondylo-arthrosis. •Osteoporosis related lumbar vertebrae complaints. •Para-vertebral lumbar muscle spasm. •Light trauma of the lumbar-sacral column. Recommended for general back pain and support.
INDACO SRL
505 S/M
In Commercial Distribution

  • 05391512286385 ()
  • 05391512282806 ()
505

  • Lumbar spine orthosis
The Blue Line M-Brace Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. made with semi-rigid fabric, it enjoys a structure made with self-modeling and flexible stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively immobilizing the lumbar-sacral region. Two rigid thermo-formable panels for lumbar and abdominal application are included. These panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. Includes two side panels moldable to provide better support (#504). The region supported extends from the sacrococcygeal joint to T-9 vertebra. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. Through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of tension settings. INDICATIONS • Lumbago, sciatica and ischialgia. • Lumbar-Sacral pain of other origin and nature. • Disc complaints. • Spondylo-arthrosis. • osteoporosis related lumbar vertebrae complaints. • Para-vertebral lumbar muscle spasm. • Light trauma of the lumbar-sacral column. • Mouldable 15 inch back panel included.
INDACO SRL
504 2XL/3XL
In Commercial Distribution

  • 05391512286378 ()
  • 05391512282790 ()
504

  • Lumbar spine orthosis
The Blue Line M-Brace Lumbar-Sacral Brace acts as an immobilizing device for the lumbar-sacral region and its’ primary function is to reduce pain caused by lumbago, sciatica and ischialgia. made with semi-rigid fabric, it enjoys a structure made with self-modeling and flexible stays on which a number of rigid straps slide. When the locking system is pulled and secured at the front, the inside straps stiffen the entire structure, thus effectively immobilizing the lumbar-sacral region. Two rigid thermo-formable panels for lumbar and abdominal application are included. These panels produce intra-abdominal pressure to reduce load on discs thus reducing pain and improving post-operative outcome when used with the corset in the appropriate position. Includes two side panels moldable to provide better support (#504). The region supported extends from the sacrococcygeal joint to T-9 vertebra. Practical and easy to wear, this brace perfectly adapts to whatever size and body type, thus ensuring maximum support and comfort at the desired tension. Through a new locking technology, operated by means of two crossing bands, the closing system is totally user friendly and allows a wide range of tension settings. INDICATIONS • Lumbago, sciatica and ischialgia. • Lumbar-Sacral pain of other origin and nature. • Disc complaints. • Spondylo-arthrosis. • osteoporosis related lumbar vertebrae complaints. • Para-vertebral lumbar muscle spasm. • Light trauma of the lumbar-sacral column. • Mouldable 15 inch back panel included.
INDACO SRL
504 L/XL
In Commercial Distribution

  • 05391512286361 ()
  • 05391512282783 ()
504

  • Lumbar spine orthosis
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