BoneFoam 104.LHS-BX10

GUDID 00810075281477

Head Guard - Box of 10

BONE FOAM, INC.

Freestanding patient positioner, single-use

• Primary Device ID: 00810075281477
• NIH Device Record Key: 02a7f876-d2bb-4aea-88e6-3888bded65df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BoneFoam
• Version Model Number: 104.LHS-BX10
• Catalog Number: 104.LHS-BX10
• Company DUNS: 079636174
• Company Name: BONE FOAM, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810075281477 [Unit of Use]
GS1	00810075281484 [Primary]

FDA Product Code

• CCX: Support, Patient Position

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-17
• Device Publish Date: 2024-09-09

On-Brand Devices [BoneFoam]

• 00810075281323: Universal Prone Solution - Disposable Barrier Cover - Box of 20
• 00810075281378: Made To Order - Disposable Positioner
• 00810075281361: Made To Order - Reusable Positioner
• 00810075281392: Zero Degree Knee Disposable - Box of 12
• 00810075281439: Zero Degree Knee Disposable - Box of 12
• 00810075281415: Direct Anterior Hip Positioning System - Disposable Barrier Cover - Box of 20
• 00810075281453: Pelvic Cradle - Disposable Barrier Cover - Box of 20
• 00810075281446: Pelvic Cradle
• 00810075281477: Head Guard - Box of 10