TMC PSI Cut Guide System

GUDID 00810111222310

Fixation Kit

Treace Medical Concepts, Inc.

Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 00810111222310
• NIH Device Record Key: f54108ea-388d-4813-89e9-8ec73e2d270f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TMC PSI Cut Guide System
• Version Model Number: NK14
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810111222310 [Primary]

FDA Product Code

• HWE: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

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

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

[00810111222310]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-27
• Device Publish Date: 2023-11-17

On-Brand Devices [TMC PSI Cut Guide System]

• 00810111222358: Cut Guide
• 00810111222327: Cut Guide
• 00810111222310: Fixation Kit
• 00810111222297: Cut Guide
• 00810111222280: Cut Guide
• 00810111222273: Cut Guide
• 00810111222266: Cut Guide
• 00810111222259: Lapidus Cut Guide Kit
• 00810111222730: Cut Guide
• 00810111222723: Cut Guide