Threaded Handle

GUDID 00810111224161

TMC ALLOGRAFT THREADED HANDLE

Treace Medical Concepts, Inc.

Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 00810111224161
• NIH Device Record Key: bccddf4f-208b-4cb1-9406-4071c6e9bbfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Threaded Handle
• Version Model Number: 02-00323
• 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	00810111224161 [Primary]

FDA Product Code

• HWT: Template

Sterilization

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

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

[00810111224161]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-27
• Device Publish Date: 2025-03-19

Devices Manufactured by Treace Medical Concepts, Inc.

• 00810111224079 - Lapidus Trial: 2025-03-27 TMC Lapidus Trial, 5mm
• 00810111224086 - Lapidus Trial: 2025-03-27 TMC Lapidus Trial, 9mm
• 00810111224093 - Evans Trial: 2025-03-27 TMC Evans Trial, 6mm
• 00810111224109 - Evans Trial: 2025-03-27 TMC Evans Trial, 8mm
• 00810111224116 - Evans Trial: 2025-03-27 TMC Evans Trial, 10mm
• 00810111224123 - MTP Trial: 2025-03-27 TMC MTP Trial, 5mm
• 00810111224130 - MTP Trial: 2025-03-27 TMC MTP Trial 9mm
• 00810111224147 - Cotton Trial: 2025-03-27 TMC Cotton Trial, 6mm