PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S

GUDID 04056481145439

Brainlab AG

Surgical optical-tracking spatial marker holder

• Primary Device ID: 04056481145439
• NIH Device Record Key: 690b61f3-bf5f-477e-968e-27615ea64f8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S
• Version Model Number: 55824
• 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 Dimensions

• Length: 139.7 Millimeter
• Width: 31.6 Millimeter
• Height: 45.2 Millimeter
• Length: 139.7 Millimeter
• Width: 31.6 Millimeter
• Height: 45.2 Millimeter
• Length: 139.7 Millimeter
• Width: 31.6 Millimeter
• Height: 45.2 Millimeter
• Length: 139.7 Millimeter
• Width: 31.6 Millimeter
• Height: 45.2 Millimeter
• Length: 139.7 Millimeter
• Width: 31.6 Millimeter
• Height: 45.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481145439 [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

[04056481145439]

Moist Heat or Steam Sterilization

[04056481145439]

Moist Heat or Steam Sterilization

[04056481145439]

Moist Heat or Steam Sterilization

[04056481145439]

Moist Heat or Steam Sterilization

[04056481145439]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-25
• Device Publish Date: 2025-06-17

Devices Manufactured by Brainlab AG

• 04056481145439 - PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S: 2025-06-25
• 04056481145439 - PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S: 2025-06-25
• 04056481145446 - PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L: 2025-06-25
• 04056481146320 - Alignment Software Spine: 2025-06-24 The Alignment Software Spine is intended to support the surgeon in reaching a predefined position through semi-automated alignme
• 04056481145521 - ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K): 2025-06-23
• 04056481145538 - ULTRASOUND NAVIGATION ADAPTER (ALOKA S31KP): 2025-06-23
• 04056481145828 - Microscope Navigation: 2025-06-19
• 04056481143985 - Mixed Reality Spine Navigation: 2025-06-09
• 04056481140809 - Curve 1.2 Dual Navigation Station: 2025-03-26