AccessGUDID - DEVICE: P.T. Rail: Wall Mast, Stainless Steel (00689281014410)

GUDID

Device Identifier (DI) Information

Brand Name: P.T. Rail: Wall Mast, Stainless Steel
Version or Model: PT-WRM-SS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01441
Company Name: Healthcraft Products Inc.

Primary DI Number: 00689281014410
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252468293 *Terms of Use

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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
IKX	Aid, Transfer

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 31cb9b70-222a-4160-a4cd-482514d227fc
Public Version Date: September 02, 2021
Public Version Number: 1
DI Record Publish Date: August 25, 2021