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 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
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)
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 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
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)
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)
AU10D5L25
Not in Commercial Distribution

  • M272AU10D5L251 ()
  • 10381780036104 ()

  • 10 platinum contacts


  • Depth electrode
No Description
Hertart ApS
16106
In Commercial Distribution

  • 27350025914606 ()
  • 17350025914609 ()
  • 07350025914602 ()


  • Assisted reproduction centrifuge tube
No Description
Hertart ApS
16105
In Commercial Distribution

  • 27350025914590 ()
  • 17350025914593 ()
  • 07350025914596 ()


  • Assisted reproduction centrifuge tube
No Description
Hertart ApS
16103
In Commercial Distribution

  • 17350025914579 ()
  • 27350025914576 ()
  • 07350025914572 ()


  • Assisted reproduction centrifuge tube
No Description
Hertart ApS
16101
In Commercial Distribution

  • 07350025914558 ()
  • 17350025914555 ()
  • 27350025914552 ()


  • Assisted reproduction centrifuge tube
CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm
Helios Cardio Inc.
CMUS-05NS-0506
In Commercial Distribution

  • 00850023375087 ()

  • Length: 5 Centimeter
  • Width: 6 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0506

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 7 x 15 cm
Helios Cardio Inc.
CMUS-10NS-0715
In Commercial Distribution

  • 00850023375070 ()

  • Width: 15 Centimeter
  • Height: 1.0 Millimeter
  • Length: 7 Centimeter
CMUS-10NS-0715

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm
Helios Cardio Inc.
CMUS-10NS-0812
In Commercial Distribution

  • 00850023375063 ()

  • Length: 8 Centimeter
  • Width: 12 Centimeter
  • Height: 1.0 Millimeter
CMUS-10NS-0812

  • Cardiovascular patch, animal-derived
CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 4 x 7 cm
Helios Cardio Inc.
CMUS-05NS-0407
In Commercial Distribution

  • 00850023375056 ()

  • Length: 4 Centimeter
  • Width: 7 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0407

  • Cardiovascular patch, animal-derived
CardiaMend 0.5 Pericardial and Epicardial Reconstruction Matrix 8 x 12 cm
Helios Cardio Inc.
CMUS-05NS-0812
In Commercial Distribution

  • 00850023375049 ()

  • Length: 8 Centimeter
  • Width: 12 Centimeter
  • Height: 0.5 Millimeter
CMUS-05NS-0812

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 10 x 15 cm
Helios Cardio Inc.
CMUS-10NS-1015
In Commercial Distribution

  • 00850023375032 ()

  • Length: 10 Centimeter
  • Width: 15 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-1015

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 5 x 6 cm
Helios Cardio Inc.
CMUS-10NS-0506
In Commercial Distribution

  • 00850023375025 ()

  • Length: 5 Centimeter
  • Width: 6 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0506

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 16 cm
Helios Cardio Inc.
CMUS-10NS-0816
In Commercial Distribution

  • 00850023375018 ()

  • Length: 8 Centimeter
  • Width: 16 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0816

  • Cardiovascular patch, animal-derived
CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 6 x 12 cm
Helios Cardio Inc.
CMUS-10NS-0612
In Commercial Distribution

  • 00850023375001 ()

  • Length: 6 Centimeter
  • Width: 12 Centimeter
  • Height: 1 Millimeter
CMUS-10NS-0612

  • Cardiovascular patch, animal-derived
Decellularized Bovine Pericardium
GENESEE BIOMEDICAL, INC.
PFP6x8
In Commercial Distribution

  • B040PFP6X81 ()
N/A

  • Cardiovascular patch, animal-derived
Prometra II 40ml Programmable Pump
Flowonix Medical, Inc.
16827
In Commercial Distribution

  • 00810335020242 ()


  • Implantable intrathecal infusion pump, programmable
The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. To help increase safety, the Prometra II Pump incorporates a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a high flow rate occurs, such as during an MRI. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. The Prometra II Pump contains a metal bellows drug reservoir with a capacity of 20 milliliters (mL). The reservoir propellant is stored within the rigid housing surrounding the bellows and provides the driving pressure for the pump. The driving pressure on the reservoir forces the infusate through an outlet filter (0.22 pm), and into an electronically controlled flow metering valve-accumulator subsystem. The Infumorph passes from the flow metering subsystem, into the catheter access port then into the catheter for delivery to the intrathecal space.
Flowonix Medical, Inc.
13827
In Commercial Distribution

  • 00810335020228 ()


  • Implantable intrathecal infusion pump, programmable
The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter.
Flowonix Medical, Inc.
11827
In Commercial Distribution

  • 00810335020082 ()


  • Implantable intrathecal infusion pump, programmable
CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution

  • 00893727002118 ()
  • 10893727002115 ()
40709

  • Assisted reproduction cryotube
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP2X9
In Commercial Distribution

  • 00690103199048 ()

  • 2 CM X 9 CM
DP2X9

  • Cardiovascular patch, animal-derived
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP08X8
In Commercial Distribution

  • 00690103199024 ()

  • 0.8 CM X 8 CM
DP08X8

  • Cardiovascular patch, animal-derived
No Description
Edwards Lifesciences LLC
4700
In Commercial Distribution

  • 00690103144178 ()

  • 10 CENTIMETERS WIDE BY 15 CENTIMETERS LONG. USER WILL TAILOR TO DESIRED SIZE.
4700

  • Cardiovascular patch, animal-derived
Bovine pericardial vascular patch
Edwards Lifesciences LLC
DP1X6
In Commercial Distribution

  • 00690103199031 ()

  • 1 CM X 6 CM
DP1X6

  • Cardiovascular patch, animal-derived
SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 50, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003894 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B51P12

  • Depth electrode
SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 42, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003887 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B40P12

  • Depth electrode
SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 34, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003870 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B33P12

  • Depth electrode
"SET OF 10 ANCHOR BOLTS, LENGTH 40MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003733 ()
  • 03664539003689 ()

  • Length 40 Millimeters Length of the self-tapping thread 10 Millimeters
ACS-140SMS-10

  • Depth electrode
"SET OF 10 ANCHOR BOLTS, LENGTH 40MM, LENGTH OF THE SELF-TAPPING THREAD 5MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003726 ()
  • 03664539003672 ()

  • Length 40 Millimeters Length of the self-tapping thread 5 Millimeters
ACS-040SMS-10

  • Depth electrode
"SET OF 10 ANCHOR BOLTS, LENGTH 35MM,LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003719 ()
  • 03664539003665 ()

  • Length 35 Millimeters Length of the self-tapping thread 10 Millimeters
ACS-135SMS-10

  • Depth electrode
"SET OF 10 ANCHOR BOLTS, LENGTH 30MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003702 ()
  • 03664539003658 ()

  • Length 30 Millimeters Length of the self-tapping thread 10 Millimeters
ACS-130SMS-10

  • Depth electrode
SET OF 10 ANCHOR BOLTS, LENGTH 25MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003696 ()
  • 03664539003641 ()

  • Length 25 Millimeters Length of the self-tapping part 10 Millimeters
ACS-125SMS-10

  • Depth electrode
TWIST DRILL FOR ANCHOR BOLT, LENGTH 250MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
In Commercial Distribution

  • 03664539003535 ()
KIP-ACS-515B

  • Depth electrode
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