K-wire Sleeve

GUDID 00810111223898

4mm Long Sleeve

Treace Medical Concepts, Inc.

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 00810111223898
• NIH Device Record Key: adb64a87-ec6e-45b7-83a3-b477964b6091
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-wire Sleeve
• Version Model Number: 02-00294
• 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	00810111223898 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[00810111223898]

Moist Heat or Steam Sterilization

[00810111223898]

Moist Heat or Steam Sterilization

[00810111223898]

Moist Heat or Steam Sterilization

[00810111223898]

Moist Heat or Steam Sterilization

[00810111223898]

Moist Heat or Steam Sterilization

[00810111223898]

Moist Heat or Steam Sterilization

[00810111223898]

Moist Heat or Steam Sterilization

[00810111223898]

Moist Heat or Steam Sterilization

[00810111223898]

Moist Heat or Steam Sterilization

[00810111223898]

Moist Heat or Steam Sterilization

[00810111223898]

Moist Heat or Steam Sterilization

[00810111223898]

Moist Heat or Steam Sterilization

[00810111223898]

Moist Heat or Steam Sterilization

[00810111223898]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-03
• Device Publish Date: 2025-08-26

On-Brand Devices [K-wire Sleeve]

• 00810111222754: K-Wire Sleeve
• 00810111224567: 3mm Short Sleeve
• 00810111223898: 4mm Long Sleeve
• 00810111223881: 3mm Long Sleeve
• 00810111223874: 4mm Short Sleeve