AccessGUDID - DEVICE: Walking Harness - Tollos (00817956023126)

GUDID

Device Identifier (DI) Information

Brand Name: Walking Harness - Tollos
Version or Model: TSC015WSXXX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 1073849 Ontario Limited

Primary DI Number: 00817956023126
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049181763 *Terms of Use

Device Description: Walking Harness - XXLarge - Orange Binding - 4 Loop - Tricot Material - Reuseable

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Gait rehabilitation system harness	A lifting device, in the form of belts and straps, which is a component of a gait rehabilitation system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. The device is designed to be secured around the patient?s upper body and hips and is intended to help suspend the patient vertically over the floor or a treadmill while attached to the supporting frame of a suspension device; it may be used in conjunction with a robotic orthosis device for the training of normal gait.

GMDN Preferred Term Name

GMDN Definition

Gait rehabilitation system harness

A lifting device, in the form of belts and straps, which is a component of a gait rehabilitation system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. The device is designed to be secured around the patient?s upper body and hips and is intended to help suspend the patient vertically over the floor or a treadmill while attached to the supporting frame of a suspension device; it may be used in conjunction with a robotic orthosis device for the training of normal gait.

FDA Product Code

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Product Code	Product Code Name
FSA	Lift, Patient, Non-Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Height: 21 Inch
Width: 16 Inch
Depth: 4 Inch

Device Record Status

Public Device Record Key: ecc5ba76-be96-4ea3-a64d-26fab44c6a3c
Public Version Date: December 19, 2022
Public Version Number: 1
DI Record Publish Date: December 09, 2022