AccessGUDID - DEVICE: PLUS Shampoo Shelf + Grab Bar, Oil Rubbed Bronze (00689281037211)

GUDID

Device Identifier (DI) Information

Brand Name: PLUS Shampoo Shelf + Grab Bar, Oil Rubbed Bronze
Version or Model: PLUS-SHS-ORB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03721
Company Name: Healthcraft Products Inc.

Primary DI Number: 00689281037211
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252468293 *Terms of Use

Device Description: The PLUS Shampoo Shelf is a combination grab bar and shelf, designed to disguise safety in a bathroom accessory. The PLUS Shampoo Shelf is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The PLUS Shampoo Shelf is installed with appropriate fasteners to a structural wall. The tray (which holds bottles) is NOT intended to be a support product. The maximum user weight for this product is 500lbs / 227kgs.

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):	Yes
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?
35584	Bath hand rail	A bar intended to provide a supportive hand-hold for a person with a disability when raising or lowering themselves or changing their body position while bathing in a bath or bathing facility. It will typically be affixed to or around the bath.	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: 5d3fb218-be67-463c-8b7c-cc1adc581ca4
Public Version Date: February 06, 2024
Public Version Number: 1
DI Record Publish Date: January 29, 2024