FDA UDI
In Commercial Distribution
🇺🇸 United States
PLUS Toilet Paper Holder, Oil Rubbed Bronze
DI: 00689281037266
·
Model: PLUS-TP-ORB
·
Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- PLUS Toilet Paper Holder, Oil Rubbed Bronze
- Primary DI
- 00689281037266
- Version / Model
- PLUS-TP-ORB
- Catalog Number
- 03726
- Company Name
- Healthcraft Products Inc.
- Labeler DUNS
- 252468293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-29
- Public Version
- 1
- Public Version Date
- 2024-02-06
- Public Version Status
- New
- Public Device Record Key
- 91919ab1-7de3-44de-b802-88e2b0e8e8c9
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IKX | Aid, Transfer | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10689281037263 | GS1 | kraft box | 1 | In Commercial Distribution | |
| Primary | 00689281037266 | GS1 | ||||
| Package | 20689281037260 | GS1 | kraft box | 5 | In Commercial Distribution |