Bone Foam 10-910-13-C-I

GUDID 00810075280104

Troop Elevation Pillow - Coated (3-set) (includes Troop Elevation Pillow - Coated, Troop Elevation Pillow Addition - Coated, Head Cradle - Coated)

BONE FOAM, INC.

Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable Freestanding patient positioner, reusable

• Primary Device ID: 00810075280104
• NIH Device Record Key: e327ba96-8a4d-4451-8007-5d2382938c10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Foam
• Version Model Number: 10-910-13-C-I
• Catalog Number: 10-910-13-C-I
• Company DUNS: 079636174
• Company Name: BONE FOAM, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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	00810075280104 [Primary]

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