AccessGUDID - DEVICE: Easy Mount Grab Bar, 18", Matte Black (00689281035873)

GUDID

Device Identifier (DI) Information

Brand Name: Easy Mount Grab Bar, 18", Matte Black
Version or Model: G125BLK18F9
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03587
Company Name: Healthcraft Products Inc.

Primary DI Number: 00689281035873
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252468293 *Terms of Use

Device Description: The HealthCraft Easy Mount Grab Bar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Easy Mount Grab Bar is installed with appropriate fasteners to a structural wall. The maximum user weight for this product is 500lbs / 227kg for bar lengths of 18”.

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):	Yes
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: fa21af8e-7be8-4f28-83ba-9e0f655339c6
Public Version Date: November 25, 2022
Public Version Number: 1
DI Record Publish Date: November 17, 2022