Guide Sleeve

GUDID 00810111222846

Screw Sleeve

Treace Medical Concepts, Inc.

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 00810111222846
• NIH Device Record Key: ae379602-f5b9-4b07-b7b7-2e472bec29c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Sleeve
• Version Model Number: 02-00209
• 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	00810111222846 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[00810111222846]

Moist Heat or Steam Sterilization

[00810111222846]

Moist Heat or Steam Sterilization

[00810111222846]

Moist Heat or Steam Sterilization

[00810111222846]

Moist Heat or Steam Sterilization

[00810111222846]

Moist Heat or Steam Sterilization

[00810111222846]

Moist Heat or Steam Sterilization

[00810111222846]

Moist Heat or Steam Sterilization

[00810111222846]

Moist Heat or Steam Sterilization

[00810111222846]

Moist Heat or Steam Sterilization

[00810111222846]

Moist Heat or Steam Sterilization

[00810111222846]

Moist Heat or Steam Sterilization

[00810111222846]

Moist Heat or Steam Sterilization

[00810111222846]

Moist Heat or Steam Sterilization

[00810111222846]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-08
• Device Publish Date: 2024-10-31

On-Brand Devices [Guide Sleeve]

• 00810111221702: Guide Sleeve
• 00810111221696: Guide Sleeve
• 00810111222853: Parallel Guide
• 00810111222846: Screw Sleeve