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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ICM-000-0644 STERIS Laser Sensor
I.C. MEDICAL, INC.
SSESEN02
In Commercial Distribution

  • 00817688023517 ()
SSESEN02

  • Surgical plume evacuation system
ICM-000-0643 STERIS RF Sensor, Shielded
I.C. MEDICAL, INC.
SSESEN01
In Commercial Distribution

  • 00817688023500 ()
SSESEN01

  • Surgical plume evacuation system
ICM-000-0606 STERIS Large Coconut Charcoal Output Filter, Non-Sterile
I.C. MEDICAL, INC.
SSEFIL02
In Commercial Distribution

  • 00817688023012 ()
SSEFIL02

  • Surgical plume evacuation system
ICM-000-0604 STERIS Hydrophobic ULPA Filter with Built-in Fluid Trap, Non-Sterile
I.C. MEDICAL, INC.
SSEFIL01
In Commercial Distribution

  • 00817688023005 ()
  • 00817688022992 ()
SSEFIL01

  • Surgical plume evacuation system
ICM-460-0001 STERIS Smoke Evacuation System
I.C. MEDICAL, INC.
SSECAPREG
In Commercial Distribution

  • 00817688022985 ()
SSECAPREG

  • Surgical plume evacuation system
ICM-450-0001 STERIS Smoke Evacuation System Plus
I.C. MEDICAL, INC.
SSECAPPLS
In Commercial Distribution

  • 00817688022978 ()
SSECAPPLS

  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0561
In Commercial Distribution

  • 00817688022411 ()


  • Surgical plume evacuation system
ICM-470-0005
I.C. MEDICAL, INC.
2200J
Not in Commercial Distribution

2200J

  • Surgical plume evacuation system
ICM-000-0422
I.C. MEDICAL, INC.
2250J
Not in Commercial Distribution

2250J

  • Surgical plume evacuation system
ICM-360-0002
I.C. MEDICAL, INC.
2100J
Not in Commercial Distribution

2100J

  • Surgical plume evacuation system
ICM-000-0420
I.C. MEDICAL, INC.
2210J
Not in Commercial Distribution

  • 00817688022350 ()
  • 00817688022343 ()
  • 00817688021476 ()
2210J

  • Surgical plume evacuation system
Crystal Vision Model 250D
I.C. MEDICAL, INC.
ICM-250-0000
In Commercial Distribution

  • 00817688021902 ()
ICM-250-0000

  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-460-0000
In Commercial Distribution

  • 00817688021896 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-450-0000
In Commercial Distribution

  • 00817688021889 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
2200
Not in Commercial Distribution

  • 00817688021872 ()
ICM-470-0005

  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-470-0004
In Commercial Distribution

  • 00817688021865 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-470-0000
In Commercial Distribution

  • 00817688021858 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
2100
Not in Commercial Distribution

  • 00817688021841 ()
ICM-360-0002

  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-360-0001
In Commercial Distribution

  • 00817688021834 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-360-0000
In Commercial Distribution

  • 00817688021827 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0447
In Commercial Distribution

  • 00817688021797 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0460
In Commercial Distribution

  • 00817688021780 ()
  • 00817688021773 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0546
In Commercial Distribution

  • 00817688021759 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
2250
Not in Commercial Distribution

  • 00817688021742 ()
ICM-000-0422

  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0018
In Commercial Distribution

  • 00817688021735 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0009
In Commercial Distribution

  • 00817688021711 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
2220
Not in Commercial Distribution

  • 00817688021704 ()
ICM-000-0421

  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0025
In Commercial Distribution

  • 00817688021698 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0289
In Commercial Distribution

  • 00817688021681 ()
  • 00817688021674 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0276
In Commercial Distribution

  • 00817688021667 ()
  • 00817688021650 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0262
In Commercial Distribution

  • 00817688021643 ()
  • 00817688021636 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
ICM-000-0434
In Commercial Distribution

  • 00817688021506 ()
  • 00817688021490 ()


  • Surgical plume evacuation system
No Description
I.C. MEDICAL, INC.
2210
Not in Commercial Distribution

  • 00817688021483 ()
  • 00817688021476 ()
ICM-000-0420

  • Surgical plume evacuation system
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
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
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
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
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
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
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
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
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
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
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
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
In Commercial Distribution

  • M272AU10D5L251 ()
  • 10381780036104 ()

  • 10 platinum contacts


  • Depth electrode
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