AccessGUDID - DEVICE: Steady Aid - Tollos (00817956026004)

GUDID

Device Identifier (DI) Information

Brand Name: Steady Aid - Tollos
Version or Model: TSA-500-SC-SJ-SP-ST
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 1073849 Ontario Limited

Primary DI Number: 00817956026004
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049181763 *Terms of Use

Device Description: 500 lbs capacity Standard legs Optional casters Standard footplate Smart controls Internal battery

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38050	Stand-up mobile patient lifting system, electrically-powered	An electrically-powered, mobile assembly of devices designed to enable one person to lift an incapacitated patient or a person with a disability from a sitting position into a standing position and then move them from one place to another by physically pushing it with minimal effort with the occupant held secured in the standing position. Also known as a stand-up hoist or standing hoist, it typically consists of a support base on wheels with lifting mechanism, a footrest (footplate), knee/leg supports, a sling/harness, an electrical motor and batteries. It allows secure standing of a patient for toileting, dressing, and transfer.	Active	false

FDA Product Code

[?]

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: 62 Inch
Width: 32 Inch
Depth: 56 Inch

Device Record Status

Public Device Record Key: bb5e2c9c-f105-4ac2-8c8d-78e1c8c0473f
Public Version Date: December 19, 2022
Public Version Number: 1
DI Record Publish Date: December 09, 2022