AccessGUDID - DEVICE: Toilet Roll Holder (00689281013048)

GUDID

Device Identifier (DI) Information

Brand Name: Toilet Roll Holder
Version or Model: PT-TRH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01304
Company Name: Healthcraft Products Inc.

Primary DI Number: 00689281013048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252468293 *Terms of Use

Device Description: The Toilet Roll Holder is a high quality, commercial grade accessory to be used with the P.T.Rail. The Toilet Roll Holder is intended to adhere to the P.T.Rail, and hold a roll of toilet paper. The Toilet Roll Holder is not intended to be used as a weight bearing surface or injury will occur. The Toilet Roll Holder is only to be used with HealthCraft’s P.T.Rail

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?
35585	Toilet hand rail	A device of various bar-shaped designs intended to provide a person with a disability a supportive hand-hold when lowering or raising their body to or from the toilet. It may be designed to be wall-mounted or affixed to the toilet.	Active	false

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: 60aa5ef1-140a-4ee0-907d-fedcea2e4d98
Public Version Date: September 02, 2021
Public Version Number: 1
DI Record Publish Date: August 25, 2021