AccessGUDID - DEVICE: WIPEABLE GAIT BELT 54IN W/ PLASTIC BUCKLE YELLOW (00733657274516)

GUDID

Device Identifier (DI) Information

Brand Name: WIPEABLE GAIT BELT 54IN W/ PLASTIC BUCKLE YELLOW
Version or Model: 713583
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALIMED, INC.

Primary DI Number: 00733657274516
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056007248 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

GMDN Preferred Term Name	GMDN Definition
Movement-resistance gait rehabilitation device	A collection of wearable belts, vest, straps and pulleys designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) with regaining lost motor function for ambulation using movement-resistant attachments to the legs/feet. This is a non-powered device intended to be used in the home.

FDA Product Code

[?]

Product Code	Product Code Name
IKX	AID, TRANSFER

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
No Device Sizes

Device Record Status

Public Device Record Key: 682e5eca-393d-4933-a7ff-67101ac7cc60
Public Version Date: December 09, 2022
Public Version Number: 1
DI Record Publish Date: December 01, 2022