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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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Trexo Robotics - 00628719321041

Trexo Robotics Small Trexo Plus 1 Shipment
Trexo Robotics Inc.
A0001
In Commercial Distribution

  • 00628719321041 ()

  • Small
A001BPR

  • Programmable ambulation exoskeleton, clinical

KEEOGO - CLINICIAN KIT - 07540162060007

Powered walking assistance device
B-Temia Inc
5062601
In Commercial Distribution

  • 07540162060007 ()


  • Programmable ambulation exoskeleton, clinical

ReStore - 00860001744507

The device is a lightweight, wearable, battery-powered soft orthotic exosuit intended to be used to preform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia / hemiparesis due to stroke.
REWALK ROBOTICS LTD
50-40-0001
In Commercial Distribution

  • 00860001744507 ()


  • Programmable ambulation exoskeleton, clinical

ReWalk(TM) Rehabilitaiton - 00861803000327

Powered Exoskeleton - rehabilitation institution use
REWALK ROBOTICS LTD
50-30-0001
In Commercial Distribution

  • 00861803000327 ()


  • Programmable ambulation exoskeleton, clinical

Indego Therapy - M704501110001

Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
Ekso Bionics, Inc.
501-110-001
In Commercial Distribution

  • M704501110001 ()


  • Programmable ambulation exoskeleton, clinical

Indego - M704501100000

Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
Ekso Bionics, Inc.
501-100-000
In Commercial Distribution

  • M704501100000 ()


  • Programmable ambulation exoskeleton, clinical

Ekso - B1431200000

The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
Ekso Bionics, Inc.
GT
In Commercial Distribution

  • B1431200000 ()


  • Programmable ambulation exoskeleton, clinical

EksoNR - B168EKSONR0

EKSO BIONICS SYSTEM, Ekso NR
Ekso Bionics, Inc.
EKSONR
In Commercial Distribution

  • B168EKSONR0 ()
EKSONR

  • Programmable ambulation exoskeleton, clinical

EksoGT - B168EKSOGT0

EKSO BIONICS SYSTEM, Ekso GT
Ekso Bionics, Inc.
EKSOGT
In Commercial Distribution

  • B168EKSOGT0 ()
EKSOGT

  • Programmable ambulation exoskeleton, clinical

Atalante X - 03665965000129

The Atalante X by Wandercraft is a completely self-balancing walking system for people with mobility disabilities. It is a fully powered hip-knee-ankle lower body exoskeleton with 12 actuated degrees of freedom. Atalante X is self-balancing and includes dynamic-walking control. Dynamic walking allows the Atalante X to consume significantly less power and have a more natural gait. The Atalante X is a tool for physical therapy. It is meant to be highly adjustable and be applicable for various stages of physical rehabilitation, re-mobilization and exercises.
WANDERCRAFT
ATA-002-EN US
In Commercial Distribution

  • 03665965000129 ()


  • Programmable ambulation exoskeleton, clinical

Origin Beyond Plus white - D960BPX00301

Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D30mm
In Commercial Distribution

  • D960BPX00301 ()
30111610

  • Dental appliance fabrication material, ceramic

Origin Beyond Plus white - D960BPX00281

Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D28mm
In Commercial Distribution

  • D960BPX00281 ()
30111609

  • Dental appliance fabrication material, ceramic

Origin Beyond Plus white - D960BPX00251

Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D25mm
In Commercial Distribution

  • D960BPX00251 ()
30111608

  • Dental appliance fabrication material, ceramic

Origin Beyond Plus white - D960BPX00241

Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D24mm
In Commercial Distribution

  • D960BPX00241 ()
30111607

  • Dental appliance fabrication material, ceramic

Origin Beyond Plus white - D960BPX00221

Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D22mm
In Commercial Distribution

  • D960BPX00221 ()
30111606

  • Dental appliance fabrication material, ceramic

Origin Beyond Plus white - D960BPX00201

Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D20mm
In Commercial Distribution

  • D960BPX00201 ()
30111605

  • Dental appliance fabrication material, ceramic

Origin Beyond Plus white - D960BPX00181

Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D18mm
In Commercial Distribution

  • D960BPX00181 ()
30111604

  • Dental appliance fabrication material, ceramic

Origin Beyond Plus white - D960BPX00161

Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D16mm
In Commercial Distribution

  • D960BPX00161 ()
30111603

  • Dental appliance fabrication material, ceramic

Origin Beyond Plus white - D960BPX00141

Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D14mm
In Commercial Distribution

  • D960BPX00141 ()
30111602

  • Dental appliance fabrication material, ceramic

Origin Beyond Plus white - D960BPX00121

Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D12mm
In Commercial Distribution

  • D960BPX00121 ()
30111601

  • Dental appliance fabrication material, ceramic

Origin Beyond Plus white - D960BPX00101

Origin Beyond Plus white are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus white mono can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
B & D DENTAL CORP.
98D10mm
In Commercial Distribution

  • D960BPX00101 ()
30111600

  • Dental appliance fabrication material, ceramic

Super Tray inner - Origin - 09348215039905

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-36-0004
In Commercial Distribution

  • 09348215039905 ()


  • Instrument tray, reusable

Origin NS Stem Trial - 09348215087395

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7040
In Commercial Distribution

  • 09348215087395 ()


  • Surgical implant template, reusable

Origin NS Stem Trial - 09348215087388

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7030
In Commercial Distribution

  • 09348215087388 ()


  • Surgical implant template, reusable

Origin NS Stem Trial - 09348215087371

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7020
In Commercial Distribution

  • 09348215087371 ()


  • Surgical implant template, reusable

Origin NS Stem Trial - 09348215087357

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7000
In Commercial Distribution

  • 09348215087357 ()


  • Surgical implant template, reusable

Origin Short Trial Neck - 09348215081416

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-026
In Commercial Distribution

  • 09348215081416 ()


  • Surgical implant template, reusable

DJO Origin Instrument Tray - 09348215058098

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-409
In Commercial Distribution

  • 09348215058098 ()


  • Instrument tray, reusable

Origin NS Stem Trial - 09348215087401

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7050
In Commercial Distribution

  • 09348215087401 ()


  • Surgical implant template, reusable

Origin NS Stem Trial - 09348215087364

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-7010
In Commercial Distribution

  • 09348215087364 ()


  • Surgical implant template, reusable

EVO sEEG Electrode - 00856895008351

NeuroOne 35mm Anchor Bolt
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
35mm Anchor Bolt
In Commercial Distribution

  • 00856895008351 ()
NSEEG0035

  • Depth electrode

EVO sEEG Electrode - 00856895008344

NeuroOne 30mm Anchor Bolt
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
30mm Anchor Bolt
In Commercial Distribution

  • 00856895008344 ()
NSEEG0030

  • Depth electrode

EVO sEEG Electrode - 00856895008337

NeuroOne 25mm Anchor Bolt
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
25mm Anchor Bolt
In Commercial Distribution

  • 00856895008337 ()
NSEEG0025

  • Depth electrode

EVO sEEG Electrode - 00856895008320

NeuroOne 20mm Anchor Bolt
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
20mm Anchor Bolt
In Commercial Distribution

  • 00856895008320 ()
NSEEG0020

  • Depth electrode

EVO sEEG Electrode - 00856895008313

80mm x 16 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
80mm x 16 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008313 ()
NSEEG8016

  • Depth electrode

EVO sEEG Electrode - 00856895008306

68.5mm x 16 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
68.5mm x 16 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008306 ()
NSEEG6916

  • Depth electrode

EVO sEEG Electrode - 00856895008290

61.5mm x 16 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
61.5mm x 16 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008290 ()
NSEEG6216

  • Depth electrode

EVO sEEG Electrode - 00856895008283

54.5mm x 16 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
54.5mm x 16 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008283 ()
NSEEG5516

  • Depth electrode

EVO sEEG Electrode - 00856895008276

47.5mm x 14 Contact sEEG Electrode kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
47.5mm x 14 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008276 ()
NSEEG4814

  • Depth electrode

EVO sEEG Electrode - 00856895008269

40.5mm x 12 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
40.5mm x 12 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008269 ()
NSEEG4112

  • Depth electrode

EVO sEEG Electrode - 00856895008252

33.5mm x 10 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
33.5mm x 10 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008252 ()
NSEEG3410

  • Depth electrode

EVO sEEG Electrode - 00856895008245

26.5mm x 8 Contact sEEG Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
26.5mm x 8 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008245 ()
NSEEG2708

  • Depth electrode

EVO sEEG Electrode - 00856895008238

EVO sEEG Electrode 16mm x 5 Contact Electrode Kit
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
16mm x 5 Contact sEEG Electrode
In Commercial Distribution

  • 00856895008238 ()
NSEEG1605

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092992

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, 2 LOOSE CONNECTORS
PMT CORPORATION
2102-32-09-NS
In Commercial Distribution

  • 10650551092992 ()
  • 00650551092995 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.25 Inch
2102-32-09-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092961

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-05-NS
In Commercial Distribution

  • 10650551092961 ()
  • 00650551092964 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-05-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092954

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-03-NS
In Commercial Distribution

  • 10650551092954 ()
  • 00650551092957 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-32-03-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092930

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2102-31-03-NS
In Commercial Distribution

  • 10650551092930 ()
  • 00650551092933 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-31-03-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092916

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-03-NS
In Commercial Distribution

  • 10650551092916 ()
  • 00650551092919 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-32-03-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092893

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2101-31-03-NS
In Commercial Distribution

  • 10650551092893 ()
  • 00650551092896 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-31-03-NS

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092879

SPHENOIDAL ELECTRODE EEG CABLE 1.5MM SOCKET SET
PMT CORPORATION
2122NS
In Commercial Distribution

  • 10650551092879 ()
  • 00650551092872 ()
2122NS

  • Depth electrode
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