Scalpel

GUDID 00810111222785

Medial Spike Removal Tool

Treace Medical Concepts, Inc.

Scalpel, single-use

• Primary Device ID: 00810111222785
• NIH Device Record Key: 89a1897c-4e05-4d88-925d-cf261aabdd7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scalpel
• Version Model Number: 02-00193
• 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: true
• 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	00810111222785 [Primary]

FDA Product Code

• GDX: Scalpel, One-Piece

Sterilization

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

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

[00810111222785]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-12
• Device Publish Date: 2024-06-04

On-Brand Devices [Scalpel ]

• 00853114006341: SpeedRelease™ Guided Release Instrument
• 00810111221092: lateral release instrument TMC handle
• 00810111221085: lateral release instrument flat handle
• 00810111221078: lateral release instrument TMC handle
• 00810111220996: Lateral release instrument
• 00810111220897: Lateral release instrument machined - flat handle
• 00810111222785: Medial Spike Removal Tool