BoneFoam

Basic Information

• Brand Name: BoneFoam
• Primary DI: 00810075280609
• Version / Model: 925.LLB-BX10
• Catalog Number: 925.LLB-BX10
• Company Name: BONE FOAM, INC.
• Labeler DUNS: 079636174
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-05-22
• Public Version: 3
• Public Version Date: 2023-04-11
• Public Version Status: Update
• Public Device Record Key: 5a2ee287-207a-4415-b365-5d5bcdac9923
• Distribution End Date: 2022-07-07

Device Description

Lateral Leg Bolster - Box of 10

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
Unit of Use	00810075281095	GS1
Primary	00810075280609	GS1