K-Wire Sleeve

GUDID 00810111222754

K-Wire Sleeve

Treace Medical Concepts, Inc.

Surgical drill guide, reusable

• Primary Device ID: 00810111222754
• NIH Device Record Key: bf12d8f4-0b4e-4168-b116-b817043c3b68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Wire Sleeve
• Version Model Number: 02-00196
• 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	00810111222754 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[00810111222754]

Moist Heat or Steam Sterilization

[00810111222754]

Moist Heat or Steam Sterilization

[00810111222754]

Moist Heat or Steam Sterilization

[00810111222754]

Moist Heat or Steam Sterilization

[00810111222754]

Moist Heat or Steam Sterilization

[00810111222754]

Moist Heat or Steam Sterilization

[00810111222754]

Moist Heat or Steam Sterilization

[00810111222754]

Moist Heat or Steam Sterilization

[00810111222754]

Moist Heat or Steam Sterilization

[00810111222754]

Moist Heat or Steam Sterilization

[00810111222754]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-29
• Device Publish Date: 2024-04-19

Devices Manufactured by Treace Medical Concepts, Inc.

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• 00810111223645 - Lapiplasty SpeedPlate - MicroQuad: 2024-12-05 Rapid Compression Implants
• 00810111223591 - Drill Guide: 2024-12-03 Drill Guide - 15.5MM
• 00810111223607 - Lapiplasty SpeedPlate: 2024-12-03 Micro-Quad™ Inserter Cap 15.5MM
• 00810111223393 - Drill Guide: 2024-11-27 Drill Guide and Template
• 00810111223409 - Drill Guide: 2024-11-27 Drill Guide and Template
• 00810111223416 - Depth gauge countersink: 2024-11-27 Depth gauge countersink