ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY

GUDID 04056481146610

Brainlab AG

Surgical optical-tracking spatial marker holder

• Primary Device ID: 04056481146610
• NIH Device Record Key: f1748fc1-08fe-4783-8ff0-4392c08ca311
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY
• Version Model Number: 52419A
• 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: true
• 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	04056481146610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183605

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[04056481146610]

Moist Heat or Steam Sterilization

[04056481146610]

Moist Heat or Steam Sterilization

[04056481146610]

Moist Heat or Steam Sterilization

[04056481146610]

Moist Heat or Steam Sterilization

[04056481146610]

Moist Heat or Steam Sterilization

[04056481146610]

Moist Heat or Steam Sterilization

[04056481146610]

Moist Heat or Steam Sterilization

[04056481146610]

Moist Heat or Steam Sterilization

[04056481146610]

Moist Heat or Steam Sterilization

[04056481146610]

Moist Heat or Steam Sterilization

[04056481146610]

Moist Heat or Steam Sterilization

[04056481146610]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-22
• Device Publish Date: 2024-11-14

Devices Manufactured by Brainlab AG

• 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