BoneFoam

Basic Information

• Brand Name: BoneFoam
• Primary DI: 00810075280661
• Version / Model: 925.ERLE-R-BX3
• Catalog Number: 925.ERLE-R-BX3
• Company Name: BONE FOAM, INC.
• Labeler DUNS: 079636174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• 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: 96cdd04f-45d8-4a9e-aff9-1e70afd34a48

Device Description

Edema Reduction Leg Elevator Regular - Box of 3

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
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
Unit of Use	00810075281149	GS1
Primary	00810075280661	GS1

Device Sizes

Type	Value	Unit	Text
Height	11	Inch
Length	31.5	Inch