Guide

GUDID 00810111224024

MIS Cup

Treace Medical Concepts, Inc.

Osteotomy guide, reusable

• Primary Device ID: 00810111224024
• NIH Device Record Key: 56fc601c-6f77-4ce0-81dd-5570856d4084
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide
• Version Model Number: 02-00308
• 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	00810111224024 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810111224024]

Moist Heat or Steam Sterilization

[00810111224024]

Moist Heat or Steam Sterilization

[00810111224024]

Moist Heat or Steam Sterilization

[00810111224024]

Moist Heat or Steam Sterilization

[00810111224024]

Moist Heat or Steam Sterilization

[00810111224024]

Moist Heat or Steam Sterilization

[00810111224024]

Moist Heat or Steam Sterilization

[00810111224024]

Moist Heat or Steam Sterilization

[00810111224024]

Moist Heat or Steam Sterilization

[00810111224024]

Moist Heat or Steam Sterilization

[00810111224024]

Moist Heat or Steam Sterilization

[00810111224024]

Moist Heat or Steam Sterilization

[00810111224024]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-09
• Device Publish Date: 2025-07-01

On-Brand Devices [Guide]

• 00810111224031: MIS Guide
• 00810111224024: MIS Cup