BoneFoam

Basic Information

• Brand Name: BoneFoam
• Primary DI: 00810075280524
• Version / Model: 925.PROP-R-BX5
• Catalog Number: 925.PROP-R-BX5
• Company Name: BONE FOAM, INC.
• Labeler DUNS: 079636174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-05-22
• Public Version: 2
• Public Version Date: 2023-04-11
• Public Version Status: Update
• Public Device Record Key: 5449521e-3e05-407a-88af-f9b53d3832cc

Device Description

Pelvic Raising Operative Positioner Disposable - Box of 5

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	00810075281057	GS1
Primary	00810075280524	GS1

Device Sizes

Type	Value	Unit	Text
Width	14.5	Inch
Length	22	Inch