K-Wire

GUDID 00810111221580

K-Wire

Treace Medical Concepts, Inc.

Orthopaedic intraoperative positioning pin, single-use

• Primary Device ID: 00810111221580
• NIH Device Record Key: 5bd35258-5c22-455f-9239-7a636a4f7b5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Wire
• Version Model Number: 02-00026
• 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	00810111221580 [Primary]

FDA Product Code

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

Sterilization

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

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

[00810111221580]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-01-03
• Device Publish Date: 2023-01-30

On-Brand Devices [K-Wire]

• 00810111221160: K-Wire
• 00810111221153: K-Wire
• 00810111221054: K-Wire Long Lancet
• 00810111221047: Tapered K-Wire
• 00810111221016: K-Wire
• 00810111220989: Osteotomy K-Wire
• 00810111220972: 1st MET K-Wire
• 00810111220965: 1st MET K-Wire with drill tip
• 00810111220958: K-Wire
• 00810111220866: K-Wire double trocar
• 00810111220859: K-Wire
• 00810111221450: 2.2MM DRILL
• 00810111222082: K-Wire
• 00810111222181: K-Wire
• 00810111221580: K-Wire
• 00810111222921: K-Wire