TMC PSI Cut Guide System

GUDID 00810111223478

INTELLIGUIDE™ PSI 3-2-1 CUT GUIDE SYSTEM

Treace Medical Concepts, Inc.

Custom-made orthopaedic/craniofacial surgical guide

• Primary Device ID: 00810111223478
• NIH Device Record Key: d2fa5511-4ed6-40fa-a0c6-e56c92af9e3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TMC PSI Cut Guide System
• Version Model Number: NK26
• Company DUNS: 054808082
• Company Name: Treace Medical Concepts, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00810111223478 [Primary]

FDA Product Code

• PBF: Orthopaedic Surgical Planning And Instrument Guides

Sterilization

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

[00810111223478]

Moist Heat or Steam Sterilization

[00810111223478]

Moist Heat or Steam Sterilization

[00810111223478]

Moist Heat or Steam Sterilization

[00810111223478]

Moist Heat or Steam Sterilization

[00810111223478]

Moist Heat or Steam Sterilization

[00810111223478]

Moist Heat or Steam Sterilization

[00810111223478]

Moist Heat or Steam Sterilization

[00810111223478]

Moist Heat or Steam Sterilization

[00810111223478]

Moist Heat or Steam Sterilization

[00810111223478]

Moist Heat or Steam Sterilization

[00810111223478]

Moist Heat or Steam Sterilization

[00810111223478]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-22
• Device Publish Date: 2024-11-14

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
• 00810111223621: INTELLIGUIDE™ PSI 3-2-1 MINI-INCISION CUT GUIDE SYSTEM
• 00810111223584: Adductoplasty Cut Guide - Left
• 00810111223577: Adductoplasty Cut Guide - Right
• 00810111223560: Mini-Adductoplasty Cut Guide-Left
• 00810111223553: Mini Adductoplasty Cut Guide - Right
• 00810111223478: INTELLIGUIDE™ PSI 3-2-1 CUT GUIDE SYSTEM
• 00810111223454: INTELLIGUIDE™ PSI MINI-ADDUCTOPLASTY CUT GUIDE
• 00810111223447: INTELLIGUIDE™ PSI ADDUCTOPLASTY CUT GUIDE