Device
40440 Trendelenburg One-Step Arm Protectors Low Profile
Manufacturer
XODUS MEDICAL, INC.
Model: 40440 Catalog: 40440 DI: 00787551041538 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08
Description
40440 Trendelenburg One-Step Arm Protectors Low Profile
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 5e868c56-b131-4ee5-b3ff-5c08e77b9b9b
Distribution Status: In Commercial Distribution
DUNS Number: 868042664
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: Yes
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Pkg Type: CASE
Item #1 - Device ID: 20787551041532
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 6
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00787551041538
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00787551041538
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 62292
Name: Freestanding patient positioner, single-use
Definition:
A preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.
FDA Product Codes
CCX
SUPPORT, PATIENT POSITION