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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No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Non-shielded
In Commercial Distribution

  • 07290014954458 ()
  • 17290014954455 ()
STR-000425-00

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

  • 07290014954441 ()
  • 17290014954448 ()
STR-000025-00

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

  • 07290014954434 ()
  • 17290014954431 ()
STR-001124-00

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

  • 07290014954427 ()
  • 17290014954424 ()
STR-001024-00

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

  • 07290014954410 ()
  • 17290014954417 ()
STR-000024-00

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

  • 07290014954397 ()
  • 17290014954394 ()
STR-107079-00

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

  • 07290014954373 ()
  • 17290014954370 ()
STR-000079-00

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

  • 07290014954342 ()
  • 17290014954349 ()
STR-021480-00

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

  • 07290014954335 ()
  • 17290014954332 ()
STR-007080-00

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

  • 07290014954328 ()
  • 17290014954325 ()
STR-000426-00

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

  • 07290014954311 ()
  • 17290014954318 ()
STR-000080-00

  • Depth electrode
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.
NeuroProbe
In Commercial Distribution

  • 17290014954974 ()
  • 07290014954977 ()
STR-94685Z-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
NeuroProbe
In Commercial Distribution

  • 17290014954967 ()
  • 07290014954960 ()
STR-94685L-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Sterile Neuro Omega AlphaProbe electrode's cable 10 CH
In Commercial Distribution

  • 17290014954950 ()
  • 07290014954953 ()
STR-000664-21

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

  • 17290014954875 ()
  • 07290014954878 ()
STR-050925-00

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

  • 07290014954601 ()
  • 17290014954608 ()
STR-009024-00

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

  • 07290014954557 ()
  • 17290014954554 ()
STR-901080-00

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

  • 07290014954533 ()
  • 17290014954530 ()
STR-009023-00

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

  • 07290014954502 ()
  • 17290014954509 ()
17290014954509

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

  • 07290014954496 ()
  • 17290014954493 ()
STR-34685L-00

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

  • 07290014954489 ()
  • 17290014954486 ()
STR-34685Z-00

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

  • 07290014954472 ()
  • 17290014954479 ()
STR-000925-00

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

  • 07290014954465 ()
  • 17290014954462 ()
17290014954462

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

  • 07290014954403 ()
  • 17290014954400 ()
STR-000023-00

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

  • 07290014954380 ()
  • 17290014954387 ()
STR-001079-00

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

  • 07290014954359 ()
  • 17290014954356 ()
STR-022780-00

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

  • 17290014954073 ()
  • 07290014954076 ()
STR-222291-00

  • Depth electrode
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
PUMP 8637-20 SM2 20ML EMAN US JUN BATRY
MEDTRONIC, INC.
8637-20
Not in Commercial Distribution

  • 00613994779229 ()

  • Total Volume: 20.0 Milliliter


  • Implantable intrathecal infusion pump, programmable
DEPTH ELECTRODE, PLATINUM, 2 CONTACT, MINI CONNECTOR
PMT CORPORATION
2102-02-MN-SS
In Commercial Distribution

  • 00650551101949 ()

  • Main Tube Length 32 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 15 Millimeter
  • Contact Length 5 Millimeter
2102-02-MN-SS

  • Depth electrode
MICROWIRE DEPTH ELECTRODE, 8 MACRO CONTACTS, 24 MICROWIRES, INLINE CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS
PMT CORPORATION
2104-08-24-001
In Commercial Distribution

  • 00650551098386 ()

  • Recording Depth 34.5 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 46 Centimeter
  • Contact Size 2 Millimeter
2104-08-24-001

  • Depth electrode
MICROWIRE DEPTH ELECTRODE, 5 MACRO CONTACTS, 20 MICROWIRES, INLINE CONNECTOR, 1 EXIT, 2 LEADS, 2 TAILS
PMT CORPORATION
2104-05-20-02-IL
In Commercial Distribution

  • 00650551098362 ()

  • Recording Depth 19.5 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 16.5 Centimeter
  • Contact Size 1.5 Millimeter
2104-05-20-02-IL

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-154
In Commercial Distribution

  • 00650551098133 ()

  • Main Tube Length 32 Centimeter
  • Spacing 2.4 Millimeter
  • Recording Depth 110 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-154

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-153
In Commercial Distribution

  • 00650551098126 ()

  • Main Tube Length 32 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 95 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-153

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-152
In Commercial Distribution

  • 00650551098119 ()

  • Main Tube Length 32 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-152

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-151
In Commercial Distribution

  • 00650551098102 ()

  • Main Tube Length 32 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 65 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-151

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-141
In Commercial Distribution

  • 00650551098096 ()

  • Main Tube Length 27 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 100 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-141

  • Depth electrode
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