DEVICE: PLUS Toilet Roll Holder, Matte Black (00689281037167)

Device Identifier (DI) Information

PLUS Toilet Roll Holder, Matte Black
PLUS-TP-BLK
In Commercial Distribution
03716
Healthcraft Products Inc.
00689281037167
GS1

1
252468293 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

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Product Code Product Code Name
IKX Aid, Transfer
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

fdebbc3a-189b-416a-8f57-18acefea90ae
November 25, 2022
1
November 17, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20689281037161 5 00689281037167 In Commercial Distribution carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
Yes
10689281037164
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Production Identifier(s) in UDI

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No CLOSE

Customer Contact

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No Customer Contact currently defined
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