Drill Guide Handle

GUDID 04056481144838

Brainlab AG

Surgical drill guide, reusable

• Primary Device ID: 04056481144838
• NIH Device Record Key: 7bd26bd6-f2f4-4863-8ec0-49d259de4fb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drill Guide Handle
• Version Model Number: 51839
• Company DUNS: 314482980
• Company Name: Brainlab AG
• Device Count: 1
• DM Exempt: false
• 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	04056481144838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240701

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

Moist Heat or Steam Sterilization

[04056481144838]

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 [Drill Guide Handle]

• 04056481003258: 41839A
• 04056481144838: 51839