Duns Number:252468293
Device Description: The PLUS Toilet Roll Holder is a combination grab bar and toilet roll holder, designed to The PLUS Toilet Roll Holder is a combination grab bar and toilet roll holder, designed to disguise safety in a bathroom accessory. The PLUS Toilet Roll Holder is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The PLUS 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.
Catalog Number
03505
Brand Name
PLUS Toilet Paper Holder + Grab Bar
Version/Model Number
PLUS-TP-CP
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IKX
Product Code Name
Aid, Transfer
Public Device Record Key
bc933245-c37e-4672-a2dd-84fcef5b6929
Public Version Date
February 09, 2022
Public Version Number
1
DI Record Publish Date
February 01, 2022
Package DI Number
20689281035051
Quantity per Package
5
Contains DI Package
00689281035057
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 298 |