Derotation Pin Guide

GUDID 00810111221849

Derotation Pin Guide

Treace Medical Concepts, Inc.

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• Primary Device ID: 00810111221849
• NIH Device Record Key: 891e621a-bd96-4390-a97b-773c08627f50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Derotation Pin Guide
• Version Model Number: 01-1000-009
• Company DUNS: 054808082
• Company Name: Treace Medical Concepts, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810111221849 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

[00810111221849]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-13
• Device Publish Date: 2024-02-05

Devices Manufactured by Treace Medical Concepts, Inc.

• 00810111222792 - Cut Guide: 2024-04-19 STEPPED INLINE CUT GUIDE, SMALL
• 00810111222808 - Cut Guide: 2024-04-19 STEPPED INLINE CUT GUIDE, MEDIUM
• 00810111222815 - Cut Guide: 2024-04-19 STEPPED INLINE CUT GUIDE, LARGE
• 00810111222723 - TMC PSI Cut Guide System: 2024-03-19 Cut Guide
• 00810111222730 - TMC PSI Cut Guide System: 2024-03-19 Cut Guide
• 00810111222396 - Lapiplasty SpeedPlate: 2024-02-22 Rapid Compression Implants
• 00810111221849 - Derotation Pin Guide: 2024-02-13Derotation Pin Guide
• 00810111221849 - Derotation Pin Guide: 2024-02-13 Derotation Pin Guide
• 00810111222013 - Instrument Tray: 2024-01-30 Instrument Tray