3.5mm Hex Driver 110710

GUDID 00816950029578

3.5mm Hex Driver

Osteocentric Technologies, Inc.

Surgical screwdriver, reusable

• Primary Device ID: 00816950029578
• NIH Device Record Key: 93b9c031-216f-443f-80bf-586ba9296f9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.5mm Hex Driver
• Version Model Number: 110710
• Catalog Number: 110710
• Company DUNS: 089645059
• Company Name: Osteocentric Technologies, Inc.
• 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: 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: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com
• Phone: 1-800-969-0639
• Email: quality@osteocentric.com

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816950029578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210247

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

[00816950029578]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-16
• Device Publish Date: 2024-07-08

Devices Manufactured by Osteocentric Technologies, Inc.

• 00816950029523 - QC T-Handle Quarter In Square: 2024-07-16 QC T-Handle Quarter In Square
• 00816950029547 - 5.2mm Fastener Tap: 2024-07-16 5.2mm Fastener Tap
• 00816950029554 - 6.0mm Fastener Tap: 2024-07-16 6.0mm Fastener Tap
• 00816950029561 - 3.5mm Hex Driver AO QC: 2024-07-16 3.5mm Hex Driver AO QC
• 00816950029578 - 3.5mm Hex Driver: 2024-07-163.5mm Hex Driver
• 00816950029578 - 3.5mm Hex Driver: 2024-07-16 3.5mm Hex Driver
• 00816950020773 - 34mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 34mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020797 - 36mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 36mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020810 - 38mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 38mm, 2.7mm Cortical Screw, Self-Tapping