AccessGUDID - DEVICE: Invisia™ Linear Bar (Matte Black, 1Pk, 18"/457mm) (00689281031776)

GUDID

Device Identifier (DI) Information

Brand Name: Invisia™ Linear Bar (Matte Black, 1Pk, 18"/457mm)
Version or Model: INV-LB18-BLK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03177
Company Name: Healthcraft Products Inc.

Primary DI Number: 00689281031776
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252468293 *Terms of Use

Device Description: The Invisia Linear Bar is a curved grab bar designed to disguise safety in a bathroom accessory. The Invisia Linear Bar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Invisia Linear Bar is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kgs. Note: Product is not intended to support full body weight.

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?
35586	Hand rail	A device that is fixed to the wall and is of differing bar shaped designs that is intended to provide a person with a disability a supportive hand-hold whilst standing and moving.	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: 32a5556d-713e-4aec-adda-9f4f31a55e55
Public Version Date: September 07, 2021
Public Version Number: 1
DI Record Publish Date: August 30, 2021