Osteotome

GUDID 00810111221009

Osteotome

TREACE MEDICAL CONCEPTS, INC.

Orthopaedic osteotome

• Primary Device ID: 00810111221009
• NIH Device Record Key: 691ec283-e5fa-4c61-8f87-8ebf4c01063f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteotome
• Version Model Number: 1405-2607
• 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	00810111221009 [Primary]

FDA Product Code

• HWM: Osteotome

Sterilization

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

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

[00810111221009]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-20
• Device Publish Date: 2022-09-12

On-Brand Devices [Osteotome]

• 00853114006334: TriTome™ Triple-Edge Release Instrument
• 00810111221009: Osteotome
• 00810111220910: Osteotome
• 00810111220903: Osteotome
• 00810111220606: Hooked Osteotome
• 00810111220590: Straight Osteotome
• 00810111221641: Hooked Osteotome
• 00810111221634: Square Osteotome