FDA UDI
In Commercial Distribution
🇺🇸 United States
P.T. Rai, Hinged, 32 IN. Right, Stainless Steel
DI: 00689281004060
·
Model: PT-WR32R-SS
·
Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- P.T. Rai, Hinged, 32 IN. Right, Stainless Steel
- Primary DI
- 00689281004060
- Version / Model
- PT-WR32R-SS
- Catalog Number
- 00406
- Company Name
- Healthcraft Products Inc.
- Labeler DUNS
- 252468293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-25
- Public Version
- 1
- Public Version Date
- 2021-09-02
- Public Version Status
- New
- Public Device Record Key
- 31ee5bfe-abb0-4fd7-868f-a91e1cc58f88
Device Description
The P.T.Rail is a high quality, commercial grade, fold down rail for use beside a toilet. The P.T.Rail features an offset handle to help reduce strain when gripping the lower rail. The P.T.Rail is intended for moderate vertical and horizontal load bearing to provide sitting and standing toilet support for people with reduced mobility. The P.T.Rail is intended to bear weight ONLY when the handle is in the down position; the handle is not intended to bear weight in any other position. The P.T.Rail handle is intended to be folded up when not in use. A friction hinge ensures that the handle will not inadvertently lower when it is in the up position. The P.T.Rail is installed with appropriate fasteners to a structural wall.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00689281004060 | GS1 |