AccessGUDID - DEVICE: E2 Carbon Fiber Fixed Hardware (07540147001339)

GUDID

Device Identifier (DI) Information

Brand Name: E2 Carbon Fiber Fixed Hardware
Version or Model: CFFX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CFFX
Company Name: Motion Concepts Inc

Primary DI Number: 07540147001339
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 259777209 *Terms of Use

Device Description: E2 Carbon Fiber Fixed Mounting Hardware (set). Fixed mounting hardware option for Matrx E2 Carbon Fiber Backs (16H or less). Requires tools to remove. (Fits 3/4", 7/8" or 1" back cane diameters)

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: 359d25c2-aa52-496e-81d1-2eb04127799b
Public Version Date: December 20, 2022
Public Version Number: 1
DI Record Publish Date: December 12, 2022