Bone Foam 10-910-02

GUDID 00810075281002

Head Cradle - Disposable - Box of 4

BONE FOAM, INC.

Freestanding patient positioner, single-use

• Primary Device ID: 00810075281002
• NIH Device Record Key: 03d0af10-5538-4cb7-9c53-8b1b4b29047f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Foam
• Version Model Number: 10-910-02
• Catalog Number: 10-910-02
• Company DUNS: 079636174
• Company Name: BONE FOAM, INC.
• Device Count: 4
• 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	00810075280043 [Primary]
GS1	00810075281002 [Unit of Use]

FDA Product Code

• CCX: Support, Patient Position
• EPW: Support, head, surgical, ENT

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: 2022-05-30
• Device Publish Date: 2022-05-22

On-Brand Devices [Bone Foam]

• 00810075280968: HIPPY Padded Peg Board Post Small
• 00810075280951: HIPPY Padded Peg Board Post Large
• 00810075280944: HIPPY Leg Board
• 00810075280937: HIPPY Hip Bolster
• 00810075280920: HIPPY Torso Base
• 00810075280913: HIPPY Lower Extremity Package (includes HIPPY Leg Board, two HIPPY Padded Peg Board Posts Large
• 00810075280906: HIPPY Base Package (includes HIPPY Torso Base, two HIPPY Removeable Hip Bolsters, and one Single
• 00810075280890: HIPPY Direct Anterior Hip Arthroplasty Positioning System (includes HIPPY Torso Base, two HIPPY
• 00810075281200: SideLine Positioning System Single Use Kit Box of 5
• 00810075280876: SideLine Positioning System Hip Bolster
• 00810075280869: SideLine Positioning System Axillary Bolster
• 00810075280852: SideLine Positioning System Lower Base
• 00810075280845: SideLine Positioning System Torso Base
• 00810075280838: SideLine Positioning System (includes SideLine Positioning System Torso Base, SideLine Positioni
• 00810075281194: Nextend Positioning System Single Use Kit Box of 5
• 00810075280814: Nextend Positioning System Traction Anchor
• 00810075280807: Nextend Positioning System Scapula Bolster
• 00810075280791: Nextend Positioning System Torso Base
• 00810075280784: Nextend Positioning System (includes Nextend Positioning System Torso Base, Nextend Positioning
• 00810075280777: Releaf Support Pillow
• 00810075280760: Knee Buddy Coated
• 00810075281187: Knee Buddy Extender - Box of 4
• 00810075280746: Edema Reduction Leg Elevator Twin Deluxe
• 00810075280739: Edema Reduction Leg Elevator Twin
• 00810075280722: Edema Reduction Leg Elevator Deluxe
• 00810075280715: Edema Reduction Leg Elevator Large - Coated
• 00810075280708: Edema Reduction Leg Elevator Regular - Coated
• 00810075281170: Edema Reduction Leg Elevator Heel Cut - Box of 3
• 00810075281163: Edema Reduction Leg Elevator Pediatric - Box 4
• 00810075281156: Edema Reduction Leg Elevator Large - Box of 3
• 00810075281149: Edema Reduction Leg Elevator Regular - Box of 3
• 00810075280654: Zero Degree Knee Coated
• 00810075281132: Zero Degree Knee Disposable - Box of 12
• 00810075281125: Zero Degree Knee Disposable - Box of 12
• 00810075281118: Zero Degree Knee Disposable - Box of 12
• 00810075281101: Zero Degree Knee Disposable - Box of 12
• 00810075281095: Lateral Leg Bolster - Box of 10
• 00810075281088: Prone Foam - Superior Support Pad - Box of 6
• 00810075281071: Axillary Bump Disposable - Box of 10
• 00810075280579: Axillary Bump Coated Multi-Use
• 00810075280562: Distal Radius Positioner
• 00810075280555: Pelvic Raising Operative Positioner Coated – Large
• 00810075280548: Pelvic Raising Operative Positioner Coated – Regular
• 00810075281064: Pelvic Raising Operative Positioner Disposable - Box of 5
• 00810075281057: Pelvic Raising Operative Positioner Disposable - Box of 5
• 00810075280517: Leg Cradle
• 00810075281040: Jon Urology Bolsters (Pair of Bolsters) - Box of 5 pairs
• 00810075280494: Dual Leg Support with Strap
• 00810075281033: Single Arm Support - Box of 10
• 00810075280463: The Gully Pad