Brainlab Elements Fibertracking

GUDID 04056481142186

Brainlab AG

Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software

• Primary Device ID: 04056481142186
• NIH Device Record Key: 82d242c5-0bd8-46ce-bba5-b6e1595b7abf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brainlab Elements Fibertracking
• Version Model Number: 2.0
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481142186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113732

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed
• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-08
• Device Publish Date: 2020-04-30

Devices Manufactured by Brainlab AG

• 04056481146221 - Quentry.com (Quentry Web) Quentry Gateway Quentry Desktop: 2024-04-15
• 04056481141660 - DISPOSABLE KIT FOR CIRQ WITH ROBOTIC ALIGNMENT MODULE: 2024-01-04
• 04056481144845 - Automatic Registration iMRI: 2023-11-28 Automatic Registration iMRI provides an automatic image registration for cranial indications.
• 04056481145606 - HEX SCREWDRIVER T-HANDLE (2.5 MM): 2023-10-27
• 04056481145217 - DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS): 2023-10-25
• 04056481145392 - DRAPELINK REF ADAPTER AUTO-REG IMRI: 2023-10-24
• 04056481145101 - Automatic Registration: 2023-10-02 Trade names: AUTO-REGISTRATION SOFTWARE AIRO CRANIAL, AUTO-REGISTRATION SOFTWARE AIRO CMF, AUTO-REGISTRATION SOFTWARE LOOP-X CRA
• 04056481143138 - Drill Bit Cranial 2.4/4.0: 2023-09-26