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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 - 00613994963000

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

  • 00613994963000 ()


  • 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 - 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

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

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

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

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

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

ReWalk(TM) Rehabilitaiton - 00861803000327

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

  • 00861803000327 ()


  • 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

PRIMO - 00840216105737

BELT GAIT NATURAL STRIPES WITH BLUE & RED 54"
Asp Global, LLC
GBANS54
In Commercial Distribution

  • 00840216105737 ()


  • Gait rehabilitation system harness

PRIMO/ASP MEDICAL - 00840216100138

72" GAIT BELT - NATURAL, 1/EA
Asp Global, LLC
GB72MBN
In Commercial Distribution

  • 00840216100138 ()


  • Gait rehabilitation system harness

PRIMO - 00840216117952

60" Gait Belt, Metal Buckle, Navy Blue
Asp Global, LLC
GB60MBNB
In Commercial Distribution

  • 00840216117952 ()


  • Gait rehabilitation system harness

PRIMO - 00840216117945

60" Gait Belt, Metal Buckle, Natural
Asp Global, LLC
GB60MBN
In Commercial Distribution

  • 00840216117945 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114067

72" Gait Belt, Quick Release Buckle, Pastel
Asp Global, LLC
GB72QRP
In Commercial Distribution

  • 00840216114067 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114050

72" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB72QRNRB
In Commercial Distribution

  • 00840216114050 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114043

72" Gait Belt, Quick Release Buckle, Navy Blue
Asp Global, LLC
GB72QRNB
In Commercial Distribution

  • 00840216114043 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114029

72" Gait Belt, Metal Buckle, Pastel
Asp Global, LLC
GB72MBP
In Commercial Distribution

  • 00840216114029 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114012

72" Gait Belt, Metal Buckle, Navy Blue
Asp Global, LLC
GB72MBNB
In Commercial Distribution

  • 00840216114012 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114005

60" Gait Belt, Quick Release Buckle, Pastel
Asp Global, LLC
GB60QRP
In Commercial Distribution

  • 00840216114005 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113992

60" Gait Belt, Quick Release Buckle, Navy Blue
Asp Global, LLC
GB60QRNB
In Commercial Distribution

  • 00840216113992 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113985

60" Gait Belt, Quick Release Buckle, Natural
Asp Global, LLC
GB60QRN
In Commercial Distribution

  • 00840216113985 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113978

60" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB60QRNRB
In Commercial Distribution

  • 00840216113978 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107052

BELT, QUICK CLEAN GAIT, PINK, 36", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM36PK
In Commercial Distribution

  • 00840216107052 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107045

BELT, QUICK CLEAN GAIT, BLUE, 60", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM60BL
In Commercial Distribution

  • 00840216107045 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107038

BELT, QUICK CLEAN GAIT, BLACK, 72", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM72BK
In Commercial Distribution

  • 00840216107038 ()


  • Gait rehabilitation system harness

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 - 03664539003917

GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
INSTRUMENT GUIDE
In Commercial Distribution

  • 03664539003917 ()
ACS-789/120R

  • Depth electrode

NA - 03664539003900

GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
INSTRUMENT GUIDE
In Commercial Distribution

  • 03664539003900 ()
ACS-789/82R

  • Depth electrode

NA - 03664539003894

SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 50, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003894 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B51P12

  • Depth electrode

NA - 03664539003887

SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 42, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003887 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B40P12

  • Depth electrode

NA - 03664539003870

SEEG DEPTH ELECTRODE, 6 MACRO AND 12 MICRO-CONTACTS PROXIMAL, EXPLORATION LENGTH 34, Ø 0.8MM
DIXI MEDICAL
MICRODEEP MICRO MACRO ELECTRODE
In Commercial Distribution

  • 03664539003870 ()

  • Macro Contact Length 2 Millimeters Macro Contact Spacing 2 Millimeters Proximal Micro Contact Exposure Diameter 0,02 Millimeters
MM08-06B33P12

  • Depth electrode

NA - 03664539003689

"SET OF 10 ANCHOR BOLTS, LENGTH 40MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003733 ()
  • 03664539003689 ()

  • Length 40 Millimeters Length of the self-tapping thread 10 Millimeters
ACS-140SMS-10

  • Depth electrode

NA - 03664539003672

"SET OF 10 ANCHOR BOLTS, LENGTH 40MM, LENGTH OF THE SELF-TAPPING THREAD 5MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003726 ()
  • 03664539003672 ()

  • Length 40 Millimeters Length of the self-tapping thread 5 Millimeters
ACS-040SMS-10

  • Depth electrode

NA - 03664539003665

"SET OF 10 ANCHOR BOLTS, LENGTH 35MM,LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003719 ()
  • 03664539003665 ()

  • Length 35 Millimeters Length of the self-tapping thread 10 Millimeters
ACS-135SMS-10

  • Depth electrode

NA - 03664539003658

"SET OF 10 ANCHOR BOLTS, LENGTH 30MM, LENGTH OF THE SELF-TAPPING THREAD 10MM ACCESSORY OF MICRODEEP DEPTH ELECTRODE"
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539003702 ()
  • 03664539003658 ()

  • Length 30 Millimeters Length of the self-tapping thread 10 Millimeters
ACS-130SMS-10

  • Depth electrode
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