Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm

GUDID 04056481145620

Brainlab AG

Electromagnetic/optical surgical navigation device tracking system

• Primary Device ID: 04056481145620
• NIH Device Record Key: a8069763-1199-4fb2-a970-7dd307b4517f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm
• Version Model Number: 56416
• 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	04056481145620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243698

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[04056481145620]

Moist Heat or Steam Sterilization

[04056481145620]

Moist Heat or Steam Sterilization

[04056481145620]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-04
• Device Publish Date: 2025-02-24

Devices Manufactured by Brainlab AG

• 04056481145620 - Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm: 2025-03-04
• 04056481145620 - Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm: 2025-03-04
• 04056481145637 - Alignment Guide Tube Cranial 4.9 mm / 8.0 mm: 2025-03-04
• 04056481145903 - Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm: 2025-03-04
• 04056481145910 - Drill Bit Cranial 4.5 mm /4.9 mm: 2025-03-04
• 04056481145927 - Drill Depth Stop Cranial 4.9 mm: 2025-03-04
• 04056481146047 - Cirq Robotic Tracking Array 10.0: 2025-03-04
• 04056481146337 - Alignment Software Cranial with LITT: 2025-03-04
• 04056481146719 - Sterilization Tray Cirq® Robotic Alignment LITT: 2025-03-04