iFuse Granite Implant System-iFuse-Granite+ Instrument Set

GUDID 00810055524457

Granite+ Instrument Set

Si-Bone Inc.

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• Primary Device ID: 00810055524457
• NIH Device Record Key: 0aed4c0e-3078-49b2-b131-f41115f5fb52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFuse Granite Implant System-iFuse-Granite+ Instrument Set
• Version Model Number: 400381
• Company DUNS: 830127168
• Company Name: Si-Bone Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810055524457 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810055524457]

Moist Heat or Steam Sterilization

[00810055524457]

Moist Heat or Steam Sterilization

[00810055524457]

Moist Heat or Steam Sterilization

[00810055524457]

Moist Heat or Steam Sterilization

[00810055524457]

Moist Heat or Steam Sterilization

[00810055524457]

Moist Heat or Steam Sterilization

[00810055524457]

Moist Heat or Steam Sterilization

[00810055524457]

Moist Heat or Steam Sterilization

[00810055524457]

Moist Heat or Steam Sterilization

[00810055524457]

Moist Heat or Steam Sterilization

[00810055524457]

Moist Heat or Steam Sterilization

[00810055524457]

Moist Heat or Steam Sterilization

[00810055524457]

Moist Heat or Steam Sterilization

[00810055524457]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-29
• Device Publish Date: 2024-05-21

Devices Manufactured by Si-Bone Inc.

• 00810055524457 - iFuse Granite Implant System-iFuse-Granite+ Instrument Set: 2024-05-29Granite+ Instrument Set
• 00810055524457 - iFuse Granite Implant System-iFuse-Granite+ Instrument Set: 2024-05-29 Granite+ Instrument Set
• 00810055524563 - 8-Gauge Bone Access Needle and Tamp: 2024-05-22 8-Gauge Bone Access Needle and Tamp
• 00810055524617 - iFuse INTRA X Instrument Set: 2024-05-22 iFuse INTRA X Instrument Set
• 00810055523788 - iFuse Bedrock Granite Implant System: 2024-03-25 9.5 mm x 40 mm iFuse Bedrock Granite Implant
• 00810055523795 - iFuse Bedrock Granite Implant System: 2024-03-25 9.5 mm x 45 mm iFuse Bedrock Granite Implant
• 00810055523801 - iFuse Bedrock Granite Implant System: 2024-03-25 9.5 mm x 50 mm iFuse Bedrock Granite Implant
• 00810055523818 - iFuse Bedrock Granite Implant System: 2024-03-25 9.5 mm x 55 mm iFuse Bedrock Granite Implant
• 00810055523825 - iFuse Bedrock Granite Implant System: 2024-03-25 9.5 mm x 60 mm iFuse Bedrock Granite Implant