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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MICROWIRE DEPTHALON ELECTRODE, 7 X 2MM MACRO CONTACTS, 9 X 75UM MICROWIRE CONTACTS, 30MM RECORDING LENGTH, 0.8MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-07-09-001
In Commercial Distribution

  • 00650551001799 ()


  • Depth electrode
SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACNG AND 37MM BETWEEN CONTACT 9&10 WITH 9-2MM BLANK CONTACTS, 57MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-183
In Commercial Distribution

  • 00650551001430 ()


  • Depth electrode
SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACING AND 33MM BETWEEN CONTACT 9&10 WITH 9-2MM BLANK CONTACTS, 53MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-182
In Commercial Distribution

  • 00650551001423 ()


  • Depth electrode
SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACING AND 29MM BETWEEN CONTACT 9&10 WITH 7-2MM BLANK CONTACTS, 49MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-181
In Commercial Distribution

  • 00650551001416 ()


  • Depth electrode
SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACING AND 25MM BETWEEN CONTACT 9&10 WITH 6-2MM BLANK CONTACTS, 45MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-180
In Commercial Distribution

  • 00650551001409 ()


  • Depth electrode
SEEG, 16 CONTACT, 6-2MM & 10-0.5MM CONTACT, NON-STANDARD SPACING AND 33MM BETWEEN CONTACT 9&10 WITH 8-2MM BLANK CONTACTS, 66MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-179
In Commercial Distribution

  • 00650551001393 ()


  • Depth electrode
SEEG, 16 CONTACT, 6-2MM & 10-0.5MM CONTACT, NON-STANDARD SPACING AND 27MM BETWEEN CONTACT 9&10 WITH 6-2MM BLANK CONTACTS, 60MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-178
In Commercial Distribution

  • 00650551001386 ()


  • Depth electrode
SEEG, 14 CONTACT, 2MM CONTACT SIZE, 5.33MM CTC SPACING, 71.3MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-14-147
In Commercial Distribution

  • 00650551001201 ()


  • Depth electrode
SEEG, 16 CONTACT, 2MM CONTACT SIZE, 6.53MM CTC SPACING, 100MM RECORDING DEPTH, REMOVABLE STYLET, 2.1MM DRILL
PMT CORPORATION
2102-16-156
In Commercial Distribution

  • 00650551001171 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 41MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL. NON-STERILE
PMT CORPORATION
2102-16-177-NS
In Commercial Distribution

  • 00650551001140 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 48MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL, NON-STERILE
PMT CORPORATION
2102-16-176-NS
In Commercial Distribution

  • 00650551000860 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 44.5MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL, NON-STERILE
PMT CORPORATION
2102-16-175-NS
In Commercial Distribution

  • 00650551000853 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1.5MM CONTACTS MARCO CONTACT DIA., 8 MACRO CONTACTS, 16 MICROWIRE CONTACTS, 51.1MM RECORDING LENGTH, MINI CONNECTOR, NON-STERILE
PMT CORPORATION
2104-08-16-006-NS
In Commercial Distribution

  • 00650551000471 ()


  • Depth electrode
SEEG, 16 CONTACT, 2MM CONTACT SIZE, 6MM CTC SPACING, 92MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-149
In Commercial Distribution

  • 00650551000426 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 41MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-177
In Commercial Distribution

  • 00650551000419 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 48MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-176
In Commercial Distribution

  • 00650551000402 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 44.5MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-175
In Commercial Distribution

  • 00650551000396 ()


  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, 17MM RECORDING LENGTH, 5MM SPACING, MINI CONNECTOR
PMT CORPORATION
2102-04-003
In Commercial Distribution

  • 00650551000204 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 8 X 1.5MM CONTACTS MACRO CONTACTS, 32 X 40UM MICROWIRE CONTACTS, 39.5MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-09-32-001
In Commercial Distribution

  • 00650551000150 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 9 X 1.5MM CONTACTS MACRO CONTACTS, 32 X 40UM MICROWIRE CONTACTS, 42.5MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-10-32-002
In Commercial Distribution

  • 00650551000143 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 9 X 1.5MM CONTACTS MACRO CONTACTS, 32 X 40UM MICROWIRE CONTACTS, 50MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-10-32-001
In Commercial Distribution

  • 00650551000136 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 54.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-07-57-012
In Commercial Distribution

  • 00650551000129 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 51.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-08-57-011
In Commercial Distribution

  • 00650551000112 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 49.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-07-57-010
In Commercial Distribution

  • 00650551000105 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 46.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-07-57-009
In Commercial Distribution

  • 00650551000099 ()


  • Depth electrode
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166-B
In Commercial Distribution

  • 50749756735204 ()
  • 00749756735209 ()
M5166-B

  • Gait rehabilitation system harness
Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5164
In Commercial Distribution

  • 00749756678032 ()
M5164

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5165
In Commercial Distribution

  • 00749756677776 ()
M5165

  • Gait rehabilitation system harness
GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2672-B
In Commercial Distribution

  • 50749756951789 ()
  • 00749756951784 ()
M2672-B

  • Gait rehabilitation system harness
GAIT BELT, WIPEABLE
DEROYAL INDUSTRIES, INC.
M5168-YL
In Commercial Distribution

  • 00749756947657 ()
M5168-YL

  • Gait rehabilitation system harness
Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5164-YL
In Commercial Distribution

  • 50749756999279 ()
  • 00749756999274 ()
M5164-YL

  • Gait rehabilitation system harness
Kit W/Blanket and Gait Belt
DEROYAL INDUSTRIES, INC.
MK3045-UBLG
In Commercial Distribution

  • 50749756977932 ()
  • 00749756977937 ()
MK3045-UBLG

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5167
In Commercial Distribution

  • 00749756113076 ()
M5167

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166-72
In Commercial Distribution

  • 50749756113064 ()
  • 00749756113069 ()
M5166-72

  • Gait rehabilitation system harness
Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166
In Commercial Distribution

  • 50749756113057 ()
  • 00749756113052 ()
M5166

  • Gait rehabilitation system harness
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw - Pack of 3
In Commercial Distribution

  • 37290114061408 ()
700-001330-03

  • 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)
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)
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
No Description
Bird & Cronin, LLC
08140780
In Commercial Distribution

  • 50610570004046 ()
  • 00610570004041 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140680
In Commercial Distribution

  • 50610570003612 ()
  • 00610570003617 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08146545
In Commercial Distribution

  • 50610570149945 ()
  • 00610570149940 ()


  • Gait rehabilitation system harness
Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle 2x72inch Yellow Latex Free Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT723
In Commercial Distribution

  • 10885632061646 ()
  • 20885632061643 ()


  • Gait rehabilitation system harness
Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle 2x54 Inch Yellow Latex Free Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT543
In Commercial Distribution

  • 10885632061622 ()
  • 20885632061629 ()


  • Gait rehabilitation system harness
The Optimal-G is a robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The Optimal-G enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
A
In Commercial Distribution

  • 07290017844312 ()
OG01-0000-01

  • Gait rehabilitation system harness
The ReoAmbulator model is robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The ReoAmbulator enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
B
In Commercial Distribution

  • 07290017844305 ()
RA01-0000-00

  • Gait rehabilitation system harness
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290016450620 ()
  • 17290016450627 ()
366-901079-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290016450613 ()
  • 17290016450610 ()
366-901024-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
MF-Non-Shielded
In Commercial Distribution

  • 07290016450606 ()
  • 17290016450603 ()
366-009024-00

  • Depth electrode
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