iGPS 4.3mm Drill Bit

GUDID 00810055524754

iGPS 4.3mm Drill Bit

Si-Bone Inc.

Fluted surgical drill bit, reusable

• Primary Device ID: 00810055524754
• NIH Device Record Key: 8995e050-9e78-4bf2-988b-9303feaae212
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iGPS 4.3mm Drill Bit
• Version Model Number: 503042
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810055524754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251780

FDA Product Code

• HTW: Bit, Drill

Sterilization

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

[00810055524754]

Moist Heat or Steam Sterilization

[00810055524754]

Moist Heat or Steam Sterilization

[00810055524754]

Moist Heat or Steam Sterilization

[00810055524754]

Moist Heat or Steam Sterilization

[00810055524754]

Moist Heat or Steam Sterilization

[00810055524754]

Moist Heat or Steam Sterilization

[00810055524754]

Moist Heat or Steam Sterilization

[00810055524754]

Moist Heat or Steam Sterilization

[00810055524754]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-01
• Device Publish Date: 2025-09-23

Devices Manufactured by Si-Bone Inc.

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• 00810055524778 - iGPS 8.5mm Drill Bit: 2025-10-01 iGPS 8.5mm Drill Bit
• 00810055524785 - iGPS 10.5mm Drill Bit: 2025-10-01 iGPS 10.5mm Drill Bit
• 00810055524792 - Granite iGPS 8.5mm Awl Tip Tap: 2025-10-01 Granite iGPS 8.5mm Awl Tip Tap
• 00810055524808 - Granite iGPS 9.0mm Awl Tip Tap: 2025-10-01 Granite iGPS 9.0mm Awl Tip Tap
• 00810055524815 - Granite iGPS 9.5mm Awl Tip Tap: 2025-10-01 Granite iGPS 9.5mm Awl Tip Tap
• 00810055524822 - Granite iGPS 10.0mm Awl Tip Tap: 2025-10-01 Granite iGPS 10.0mm Awl Tip Tap