Drill Bit 4.5mm AO Shank Depth Control 60-100mm for Drill Guide

GUDID 04056481145866

Brainlab AG

Fluted surgical drill bit, reusable

• Primary Device ID: 04056481145866
• NIH Device Record Key: a5c1b7e7-677e-400a-980a-99d42b49680f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drill Bit 4.5mm AO Shank Depth Control 60-100mm for Drill Guide
• Version Model Number: 41839-64
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	04056481145866 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221618

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[04056481145866]

Moist Heat or Steam Sterilization

[04056481145866]

Moist Heat or Steam Sterilization

[04056481145866]

Moist Heat or Steam Sterilization

[04056481145866]

Moist Heat or Steam Sterilization

[04056481145866]

Moist Heat or Steam Sterilization

[04056481145866]

Moist Heat or Steam Sterilization

[04056481145866]

Moist Heat or Steam Sterilization

[04056481145866]

Moist Heat or Steam Sterilization

[04056481145866]

Moist Heat or Steam Sterilization

[04056481145866]

Moist Heat or Steam Sterilization

[04056481145866]

Moist Heat or Steam Sterilization

[04056481145866]

Moist Heat or Steam Sterilization

[04056481145866]

Moist Heat or Steam Sterilization

[04056481145866]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-30
• Device Publish Date: 2024-05-22

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• 04056481144913 - CRANIAL 4PI STEREOTACTIC MASK (5 PCS.): 2024-07-26
• 04056481144920 - CRANIAL 4PI STEREOTACTIC MASK (1 PC.): 2024-07-26
• 04056481144937 - CRANIAL 4PI BASIC MASK (5 PCS.): 2024-07-26
• 04056481144944 - CRANIAL 4PI BASIC MASK (1 PC.): 2024-07-26
• 04056481144951 - CRANIAL 4PI OPEN FACE MASK (5 PCS.): 2024-07-26