Derotation Handle

GUDID 00810111221832

Derotation Handle

Treace Medical Concepts, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00810111221832
• NIH Device Record Key: 659c9544-3928-42e2-a751-d95494ab150c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Derotation Handle
• Version Model Number: 01-1000-008
• 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	00810111221832 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

[00810111221832]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-21
• Device Publish Date: 2023-11-13

Devices Manufactured by Treace Medical Concepts, Inc.

• 00810111223515 - SpeedMTP Compression Screws: 2024-11-14 Headless Compression Screws
• 00810111222693 - Ratchet Handle: 2024-11-08 Ratchet Handle
• 00810111222846 - Guide Sleeve: 2024-11-08 Screw Sleeve
• 00810111222853 - Guide Sleeve: 2024-11-08 Parallel Guide
• 00810111222860 - Elevator: 2024-11-08 Head Shifter
• 00810111222877 - Length Gage: 2024-11-08 Length Gage
• 00810111222990 - Drill: 2024-11-08 Drill, Cannulated
• 00810111223003 - Drill: 2024-11-08 Drill, Cannulated