AccessGUDID - DEVICE: Ergonomic Arm Trough (07540147002701)

GUDID

Device Identifier (DI) Information

Brand Name: Ergonomic Arm Trough
Version or Model: D-0153-EAT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EAT
Company Name: Motion Concepts Inc

Primary DI Number: 07540147002701
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 259777209 *Terms of Use

Device Description: Ergonomic Arm Trough (Molded, skinned polyurethane arm pad designed to fit the natural arm curvature; elbow cut-out allows for various arm positions) Left and right arm trough configurations available.. Mounting hardware included. Depth and width adjustable. Optional Flat Hand Pad available (sold separately).

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?
32981	Wheelchair armrest	A small platform, typically cushioned, mounted on the lateral ends of a wheelchair to provide the user with a support on which to place the arms. The position of the platform (e.g., height) may be adjustable to suit the comfort and utility of the user.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IML	Armrest, 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: 9645a0a5-cd9d-4139-8602-eae741d8bc5d
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022