Alignment Guide Tube Cranial 4.9 mm / 8.0 mm

GUDID 04056481145637

Brainlab AG

Electromagnetic/optical surgical navigation device tracking system

• Primary Device ID: 04056481145637
• NIH Device Record Key: 96139fcb-2aea-4295-884d-453c3100a14a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alignment Guide Tube Cranial 4.9 mm / 8.0 mm
• Version Model Number: 56417
• 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	04056481145637 [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

[04056481145637]

Moist Heat or Steam Sterilization

[04056481145637]

Moist Heat or Steam Sterilization

[04056481145637]

Moist Heat or Steam Sterilization

[04056481145637]

Moist Heat or Steam Sterilization

[04056481145637]

Moist Heat or Steam Sterilization

[04056481145637]

Moist Heat or Steam Sterilization

[04056481145637]

Moist Heat or Steam Sterilization

[04056481145637]

Moist Heat or Steam Sterilization

[04056481145637]

Moist Heat or Steam Sterilization

[04056481145637]

Moist Heat or Steam Sterilization

[04056481145637]

Moist Heat or Steam Sterilization

[04056481145637]

Moist Heat or Steam Sterilization

[04056481145637]

Moist Heat or Steam Sterilization

[04056481145637]

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

• 04056481145330 - CRANIAL 4PI HEADREST PLATFORM: 2025-07-04
• 04056481145347 - CRANIAL 4PI HEAD SUPPORT STANDARD: 2025-07-04
• 04056481145354 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (5 PCS.): 2025-07-04
• 04056481145361 - CRANIAL 4PI WEDGE 10 DEG.: 2025-07-04
• 04056481145378 - CRANIAL 4PI SPACER 20MM: 2025-07-04
• 04056481145453 - CRANIAL 4PI INDEXING PLATE: 2025-07-04
• 04056481145460 - CRANIAL 4PI HEAD SUPPORT WIDE: 2025-07-04
• 04056481145477 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (1 PC.): 2025-07-04