Alignment Bone Anchor Cranial 2.1/3.8

GUDID 04056481143817

Brainlab AG

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• Primary Device ID: 04056481143817
• NIH Device Record Key: 063723ae-41ff-4131-a90e-9b9bd1e7f083
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alignment Bone Anchor Cranial 2.1/3.8
• Version Model Number: 56424
• 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	04056481143817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223864

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

[04056481143817]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-26
• Device Publish Date: 2023-09-18

Devices Manufactured by Brainlab AG

• 04056481144753 - Drill Guide Array: 2024-06-12
• 04056481144760 - Drill Guide Depth Control (60 - 100 mm): 2024-06-12
• 04056481144777 - Drill Guide Depth Control (0 - 60 mm): 2024-06-12
• 04056481144784 - Drill Guide Tube (4.5 mm): 2024-06-12
• 04056481144791 - Drill Guide Tube (3.2 mm): 2024-06-12
• 04056481144807 - Drill Guide Tube (2.6 mm): 2024-06-12
• 04056481144814 - Drill Guide Tube (2.4 mm): 2024-06-12
• 04056481144821 - Drill Guide Tube (2.0 mm): 2024-06-12