Drill Guide

GUDID 00810111220002

Staple Drill Guide

TREACE MEDICAL CONCEPTS, INC.

Surgical drill guide, reusable

• Primary Device ID: 00810111220002
• NIH Device Record Key: efbabf07-c837-403f-8303-51edf7e05d3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drill Guide
• Version Model Number: 1405-2455
• 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	00810111220002 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

[00810111220002]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-20
• Device Publish Date: 2022-09-12

On-Brand Devices [Drill Guide]

• 00810111220309: Staple Drill Guide
• 00810111220019: Staple Drill Guide
• 00810111220002: Staple Drill Guide
• 00853114006365: Drill Guide - Tall
• 00810111221542: Staple Drill Guide
• 00810111221535: Staple Drill Guide
• 00810111221528: Staple Drill Guide
• 00810111221511: Staple Drill Guide
• 00810111221719: Drill Guide and Template
• 00810111221689: Drill Guide and Template
• 00810111222617: Drill Guide
• 00810111221733: Contour Drill Guide
• 00810111223409: Drill Guide and Template
• 00810111223393: Drill Guide and Template
• 00810111223591: Drill Guide - 15.5MM