BoneFoam

Basic Information

• Brand Name: BoneFoam
• Primary DI: 00810075280722
• Version / Model: 925.ERLE-DELUXE
• Catalog Number: 925.ERLE-DELUXE
• Company Name: BONE FOAM, INC.
• Labeler DUNS: 079636174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: 92f26ca5-409c-4dff-9dfc-d0e53d7aa1fb

Device Description

Edema Reduction Leg Elevator Deluxe

Device Characteristics

• Single Use: No
• 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
IQI	ORTHOSIS, LIMB BRACE	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41542	Leg/knee cushion	A soft pillow or pad intended to be placed under or between the leg(s)/knee(s) of a patient during the treatment/prevention of musculoskeletal and/or circulatory disorders. It is primarily intended for support when the patient is lying down, and may be used for one or more of the following: to reduce pressure on or between the legs, to improve postural alignment (e.g., of the spine or legs), to improve blood circulation in the lower extremities, and/or to prevent pressure sores/ulcers.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810075280722	GS1