Drill Bit 3.2 mm Depth Control (200 mm)

GUDID 04056481143206

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481143206
• NIH Device Record Key: 4188a417-a0ac-4d36-ae7b-36ba9eef03bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Drill Bit 3.2 mm Depth Control (200 mm)
• Version Model Number: 41839-37A
• 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: true
• Serial Number: false
• 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	04056481143206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212245

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[04056481143206]

Moist Heat or Steam Sterilization

[04056481143206]

Moist Heat or Steam Sterilization

[04056481143206]

Moist Heat or Steam Sterilization

[04056481143206]

Moist Heat or Steam Sterilization

[04056481143206]

Moist Heat or Steam Sterilization

[04056481143206]

Moist Heat or Steam Sterilization

[04056481143206]

Moist Heat or Steam Sterilization

[04056481143206]

Moist Heat or Steam Sterilization

[04056481143206]

Moist Heat or Steam Sterilization

[04056481143206]

Moist Heat or Steam Sterilization

[04056481143206]

Moist Heat or Steam Sterilization

[04056481143206]

Moist Heat or Steam Sterilization

[04056481143206]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-06
• Device Publish Date: 2022-04-28

On-Brand Devices [Drill Bit 3.2 mm Depth Control (200 mm)]

• 04056481141486: 41839-37
• 04056481143206: 41839-37A