Positioning Wedges

Basic Information

• Brand Name: Positioning Wedges
• Primary DI: 10850013699374
• Version / Model: SYK41-341-11
• Catalog Number: SYK41-341-11
• Company Name: GENEVA HEALTHCARE, LLC
• Labeler DUNS: 964459106
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-03
• Public Version: 1
• Public Version Date: 2019-12-11
• Public Version Status: New
• Public Device Record Key: d02a8a28-fc40-449e-ab39-96342a7f62a8

Device Description

45 Degree Positioning Wedge 24" X 24" X 12.5"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCX	Support, Patient Position	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62292	Freestanding patient positioner, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850013699374	GS1
Package	00850013699377	GS1	case	2	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]