AccessGUDID - DEVICE: MX2 Fixed Mounting Hardware (07540147000264)

GUDID

Device Identifier (DI) Information

Brand Name: MX2 Fixed Mounting Hardware
Version or Model: IMX2CFH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IMX2CFH
Company Name: Motion Concepts Inc

Primary DI Number: 07540147000264
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 259777209 *Terms of Use

Device Description: MX2 Fixed Mounting Hardware (pair) for use with the Matrx MX2 Back. (Fits 3/4", 7/8" and 1" back canes). Requires tools for removal.

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?
64619	Wheelchair back rest positioner	A bracket-like device intended to be attached to the back canes of a wheelchair to accept the wheelchair back rest (not included) and allow for the adjustment of the back rest position (e.g., angle, depth, height). It is typically in the form of a clamp with hooks of adjustable position/orientation; pins intended to secure positioning may also be included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNN	Components, Wheelchair

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: 43ba6044-ce89-4fc5-9e55-94393de85143
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022