Extended Trocar Tip Reduction Tool 322-0001

GUDID 00810074306447

Extended Trocar Tip Reduction Tool

Osteocentric Technologies, Inc.

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• Primary Device ID: 00810074306447
• NIH Device Record Key: 6a0b2b4d-69de-41d9-aa0f-31f5f33fdfeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extended Trocar Tip Reduction Tool
• Version Model Number: 322-0001
• Catalog Number: 322-0001
• 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: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com
• Phone: 1800-969-0639
• Email: quality@osteocentric.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810074306447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170021

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

[00810074306447]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-24
• Device Publish Date: 2023-08-16

Devices Manufactured by Osteocentric Technologies, Inc.

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• 00816950020810 - 38mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 38mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020834 - 40mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 40mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020858 - 42mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 42mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020872 - 44mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 44mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020896 - 46mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 46mm, 2.7mm Cortical Screw, Self-Tapping
• 00816950020919 - 48mm, 2.7mm Cortical Screw, Self-Tapping: 2024-02-19 48mm, 2.7mm Cortical Screw, Self-Tapping