Device
LPK10035 Lateral Positioning Kit
Manufacturer
XODUS MEDICAL, INC.
Model: LPK10035 Catalog: LPK10035 DI: 00787551041439 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
LPK10035 Lateral Positioning Kit
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 67f9787f-84aa-45e4-a8cd-301c04394987
Distribution Status: In Commercial Distribution
DUNS Number: 868042664
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: Yes
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: 20787551041433
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 2
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00787551041439
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00787551041439
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 65178
Name: Operating table patient positioning set, single-use
Definition:
A collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent patient sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: padded positioners dedicated to a body part such as arm, leg, shoulder, neck, or feet positioner, a headrest, a non-slip pad/bolster placed underneath the patient (e.g., cervical notch), and securing devices (e.g., straps). This is a single-use device.
FDA Product Codes
CCX
SUPPORT, PATIENT POSITION