NanoBone® SBX Putty

GUDID 14260418440512

Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered nanocrystalline hydroxyapatite in a porous silica gel matrix) embedded in an aqueous gel

Biocomposites GmbH

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: 14260418440512
• NIH Device Record Key: b2f74a07-12c7-411c-bb17-288ee356a5e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NanoBone® SBX Putty
• Version Model Number: 200051
• Company DUNS: 332760383
• Company Name: Biocomposites GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com
• Phone: +4903818069940
• Email: infogermany@biocomposites.com

Device Dimensions

• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter
• Total Volume: 2.5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	14260418440512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190110

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-30
• Device Publish Date: 2023-11-22

On-Brand Devices [NanoBone® SBX Putty ]

• 14260418440536: Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered
• 14260418440529: Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered
• 14260418440512: Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered
• 14260418440499: Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered
• 14260418440505: Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered
• 14260418440482: Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered
• 14260418440475: Synthetic biodegradable bone graft substitute consisting of NanoBone® | granulate (non-sintered