AccessGUDID - DEVICE: Modular Arm Pads (I-skin) (07540147002749)

GUDID

Device Identifier (DI) Information

Brand Name: Modular Arm Pads (I-skin)
Version or Model: D-0153-MAP-IS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MAP-IS
Company Name: Motion Concepts Inc

Primary DI Number: 07540147002749
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 259777209 *Terms of Use

Device Description: Modular Arm Pads (Highly durable skinned polyurethane resists cracking and peeling and provides extra comfort and protection for arms) Modular I-Skin Armpads are available in Desk length 10" or Full length 14". Mounting hardware included. Depth and width adjustable. Left and Right armrest configurations available. Optional wheelchair component for use with Motion Concepts power positioning systems.

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: 9729d9bb-326e-4460-9cbf-4b484f8f47d7
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022