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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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Medtronic Reusable Instruments - 00613994922175

HOLDER EX1210102 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1210102
In Commercial Distribution

  • 00613994922175 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994922168

POSITIONER EX1110248 GRAFT GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
EX1110248
In Commercial Distribution

  • 00613994922168 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994994998

IMPACTOR X0411311 GRAFT 45 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0411311
In Commercial Distribution

  • 00613994994998 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994994981

IMPACTOR X0411310 GRAFT 15 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0411310
In Commercial Distribution

  • 00613994994981 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994994974

PUSHER X0411304 GRAFT MEDIUM
MEDTRONIC SOFAMOR DANEK, INC.
X0411304
In Commercial Distribution

  • 00613994994974 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994994967

PUSHER X0411303 GRAFT SMALL
MEDTRONIC SOFAMOR DANEK, INC.
X0411303
In Commercial Distribution

  • 00613994994967 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994992543

LOADING BLOCK EX0311274 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0311274
In Commercial Distribution

  • 00613994992543 ()


  • Bone graft packing block

n/a - 00613994933423

TROUGH EX0910177 BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0910177
In Commercial Distribution

  • 00613994933423 ()


  • Bone graft packing block

n/a - 00613994933409

TROUGH EX0810836 BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0810836
In Commercial Distribution

  • 00613994933409 ()


  • Bone graft packing block

Medtronic Reusable Instruments - 00613994963000

TROUGH EX1110104 GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1110104
In Commercial Distribution

  • 00613994963000 ()


  • Bone graft packing block

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

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

KEEOGO - CLINICIAN KIT - 07540162060007

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

  • 07540162060007 ()


  • 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

ReWalk(TM) Rehabilitaiton - 00861803000327

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

  • 00861803000327 ()


  • 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

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

Trexo Robotics - 00628719321072

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

  • 00628719321072 ()

  • XL
A001BPX

  • Programmable ambulation exoskeleton, clinical

Trexo Robotics - 00628719321065

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

  • 00628719321065 ()

  • Large
A001BPR

  • Programmable ambulation exoskeleton, clinical

Trexo Robotics - 00628719321058

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

  • 00628719321058 ()

  • Medium
A001BPR

  • Programmable ambulation exoskeleton, clinical

Trexo Robotics - 00628719321041

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

  • 00628719321041 ()

  • Small
A001BPR

  • Programmable ambulation exoskeleton, clinical

Morning Walk - 08800043810121

No Description
CUREXO, Inc.
MW-V100
In Commercial Distribution

  • 08800043810121 ()


  • Treadmill/elliptical gait rehabilitation system

Morning Walk - 08800043810022

MW-S200
CUREXO, Inc.
MW-S200
In Commercial Distribution

  • 08800043810022 ()
AC-00000-000

  • Treadmill/elliptical gait rehabilitation system

NA - 03664539002910

COAGULATION ELECTRODE FOR DURA, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
COAGULATION ELECTRODE AND STOP
In Commercial Distribution

  • 03664539002910 ()
KIP-ACS-600

  • Depth electrode

NA - 03664539002811

TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 160MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002811 ()
KIP-ACS-519

  • Depth electrode

NA - 03664539002804

TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 190MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002804 ()
KIP-ACS-518

  • Depth electrode

NA - 03664539002798

TWIST DRILL FOR ANCHOR BOLT, QUICK LOCKING SHANK, LENGTH 192MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002798 ()
KIP-ACS-517

  • Depth electrode

NA - 03664539002781

TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 157MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002781 ()
KIP-ACS-516

  • Depth electrode

NA - 03664539002774

TWIST DRILL FOR ANCHOR BOLT, LENGTH 200MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
In Commercial Distribution

  • 03664539002774 ()
KIP-ACS-515

  • Depth electrode

NA - 03664539002743

TWIST DRILL FOR ANCHOR BOLT, SQUARE SHANK, LENGTH 124MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002743 ()
KIP-ACS-513

  • Depth electrode

NA - 03664539002729

TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 125MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002729 ()
KIP-ACS-512

  • Depth electrode

NA - 03664539002712

TWIST DRILL FOR ANCHOR BOLT, LENGTH 140MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
Not in Commercial Distribution

  • 03664539002712 ()
KIP-ACS-511

  • Depth electrode

NA - 03664539002699

TWIST DRILL FOR ANCHOR BOLT, LENGTH 140MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
DRILL AND STOP
In Commercial Distribution

  • 03664539002699 ()
KIP-ACS-510

  • Depth electrode

NA - 03664539002446

5 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002446 ()
ADP-05

  • Depth electrode

NA - 03664539002422

8 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002422 ()
ADP-08

  • Depth electrode

NA - 03664539002415

10 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002415 ()
ADP-10

  • Depth electrode

NA - 03664539002408

12 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002408 ()
ADP-12

  • Depth electrode

NA - 03664539002392

15 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002392 ()
ADP-15

  • Depth electrode

NA - 03664539002385

18 CONTACTS, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ADAPTER
In Commercial Distribution

  • 03664539002385 ()
ADP-18

  • Depth electrode

NA - 03664539002279

LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
Not in Commercial Distribution

  • 03664539002279 ()

  • Length: 300 Centimeter
PCP-18A/300

  • Depth electrode

NA - 03664539002262

LENGTH 90CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
Not in Commercial Distribution

  • 03664539002262 ()

  • Length: 90 Centimeter
PCP-18A/90

  • Depth electrode

NA - 03664539002231

LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
In Commercial Distribution

  • 03664539002231 ()

  • Length: 300 Centimeter
PCP-18/300

  • Depth electrode

NA - 03664539002217

LENGTH 90CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
In Commercial Distribution

  • 03664539002217 ()

  • Length: 90 Centimeter
PCP-18/90

  • Depth electrode

NA - 03664539002187

18 CONTACTS, LENGTH 300CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539002187 ()

  • Length: 300 Centimeter
CBL-18/300

  • Depth electrode

NA - 03664539002170

18 CONTACTS, LENGTH 180CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539002170 ()

  • Length: 180 Centimeter
CBL-18/180

  • Depth electrode

NA - 03664539002163

18 CONTACTS, LENGTH 150CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539002163 ()

  • Length: 150 Centimeter
CBL-18/150

  • Depth electrode

NA - 03664539002156

18 CONTACTS, LENGTH 120CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
In Commercial Distribution

  • 03664539002156 ()

  • Length: 120 Centimeter
CBL-18/120

  • Depth electrode

NA - 03664539002118

18 CONTACTS, LENGTH 30CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
CONNECTION CABLE
Not in Commercial Distribution

  • 03664539002118 ()

  • Length: 30 Centimeter
CBL-18/30

  • Depth electrode
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