Sterilization Tray Drill Guide

GUDID 04056481145491

Brainlab AG

Device sterilization/disinfection container, reusable

• Primary Device ID: 04056481145491
• NIH Device Record Key: 8ddd9b9f-20b6-417d-a9d6-0991d7806d8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilization Tray Drill Guide
• Version Model Number: 52321
• Company DUNS: 314482980
• Company Name: Brainlab AG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• 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	04056481145491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240701

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-03
• Device Publish Date: 2024-05-24

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