FDA.report

Invisia™ Wall Toilet Roll Holder (Polished Chrome, 1Pk)

Primary DI
00689281033718
Brand
Invisia™ Wall Toilet Roll Holder (Polished Chrome, 1Pk)
Company
Healthcraft Products Inc.
Model
INV-WTRH-CP
Catalog number
03371
Device description
The Invisia Toilet Roll Holder is a combination grab bar and toilet roll holder, designed to disguise safety in a bathroom accessory. The Invisia Toilet Roll Holder is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Invisia Toilet Roll Holder is installed with appropriate fasteners to a structural wall. The paper axle (which holds a roll of toilet paper) is NOT intended to be a support product. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight.
Published
2021-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IKXAid, Transfer

Product Code Classifications

CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00689281033718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00689281033718006892810337186892810337180689281033718

GMDN Terms

TermDefinition
Bath hand railA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
252468293
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00689281008242Invisia Shower Bench, 24", Light, Matte GreyINV-WSSB-24-LIGHT-PCG008242022-11-17
00689281008259Invisia Shower Bench, 24", Light, Matte WhiteINV-WSSB-24-LIGHT-WHT008252022-11-17
00689281008266Invisia Shower Bench, 24", Medium, BlackINV-WSSB-24-MEDIUM-BLK008262022-11-17
00689281008273Invisia Shower Bench, 24", Medium, Matte GreyINV-WSSB-24-MEDIUM-PCG008272022-11-17
00689281035484Invisia Bath Bench, 30", Medium, BlackINV-WSBB-30-MEDIUM-BLK2022-11-17
00689281035491Invisia Bath Bench, 30", Medium, Brushed StainlessINV-WSBB-30-MEDIUM-BS035492022-11-17

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