P.T. Rail™, Hinged, (Brushed Stainless Steel, 36"/91cm, Left) - The P.T.Rail is a high quality, commercial grade, - Healthcraft Products Inc.

Duns Number:252468293

Device Description: The P.T.Rail is a high quality, commercial grade, fold down rail for use beside a toilet. 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. The maximum user weight for this product is 400lbs / 181kgs. Note: Product is not intended to support full body weight.

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More Product Details

Catalog Number

03523

Brand Name

P.T. Rail™, Hinged, (Brushed Stainless Steel, 36"/91cm, Left)

Version/Model Number

PT-WR36L-SS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IKX

Product Code Name

Aid, Transfer

Device Record Status

Public Device Record Key

b8fa4b2c-daac-4143-8514-4f61f00bbac7

Public Version Date

September 07, 2021

Public Version Number

1

DI Record Publish Date

August 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HEALTHCRAFT PRODUCTS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 298