FDA UDI
In Commercial Distribution
🇺🇸 United States
P.T. Rail: Wall Mast, White
DI: 00689281014106
·
Model: PT-WRM-PCW
·
Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- P.T. Rail: Wall Mast, White
- Primary DI
- 00689281014106
- Version / Model
- PT-WRM-PCW
- Catalog Number
- 01410
- 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
- a5273c31-48bd-491b-98b6-5879668630df
Device Description
The P.T.Rail Floor Mast is a high quality, commercial grade, floor mounted post that supports a P.T.Rail. The Floor Mast is a floor mounted structural member intended to provide a mounting surface for a P.T.Rail (in cases where wall fastening is not an option). The Floor Mast is installed with appropriate fasteners to a structural floor. The P.T.Rail is height adjustable on the Floor Mast. Must use supplied fasteners to install P.T.Rail to Floor Mast. The maximum user weight for this product is 400lbs / 181kgs
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 | 00689281014106 | GS1 |