AccessGUDID - DEVICE: Easy Mount™ 9 Hole Flange w/Cover (24" White) (00689281006422)

GUDID

Device Identifier (DI) Information

Brand Name: Easy Mount™ 9 Hole Flange w/Cover (24" White)
Version or Model: G125SW24F9
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00642
Company Name: Healthcraft Products Inc.

Primary DI Number: 00689281006422
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252468293 *Terms of Use

Device Description: A high quality 18" powder coat white steel grab bar that is fixed to the wall and is intended to provide a person with a disability a supportive hand-hold whilst standing and moving. This grab bar may be installed in any room of the home.

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: de918565-b36c-40f1-95fd-e6ad0d854121
Public Version Date: September 02, 2021
Public Version Number: 1
DI Record Publish Date: August 25, 2021