Patient Reference Rod-Clamp Spine & Trauma

GUDID 04056481146054

Brainlab SE

Surgical optical-tracking spatial marker holder

• Primary Device ID: 04056481146054
• NIH Device Record Key: 499d3052-4aae-41c5-a2cd-55cef11673ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Reference Rod-Clamp Spine & Trauma
• Version Model Number: 55826
• Company DUNS: 314482980
• Company Name: Brainlab SE
• 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	04056481146054 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252562

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[04056481146054]

Moist Heat or Steam Sterilization

[04056481146054]

Moist Heat or Steam Sterilization

[04056481146054]

Moist Heat or Steam Sterilization

[04056481146054]

Moist Heat or Steam Sterilization

[04056481146054]

Moist Heat or Steam Sterilization

[04056481146054]

Moist Heat or Steam Sterilization

[04056481146054]

Moist Heat or Steam Sterilization

[04056481146054]

Moist Heat or Steam Sterilization

[04056481146054]

Moist Heat or Steam Sterilization

[04056481146054]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-29
• Device Publish Date: 2025-09-19

Devices Manufactured by Brainlab SE

• 04056481146054 - Patient Reference Rod-Clamp Spine & Trauma: 2025-09-29
• 04056481146054 - Patient Reference Rod-Clamp Spine & Trauma: 2025-09-29
• 04056481145613 - Vascular Navigation PAD: 2025-09-19
• 04056481141981 - HIP7: 2025-09-17