Leksell Vantage Stereotactic System 1040090

GUDID 07340201501634

VANTAGE RADIOLUCENT STARBURST 1/2"

Elekta Solutions AB

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• Primary Device ID: 07340201501634
• NIH Device Record Key: 18da0311-20fe-4233-aafc-0ff8d88667e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Vantage Stereotactic System
• Version Model Number: 1040090
• Catalog Number: 1040090
• Company DUNS: 353272181
• Company Name: Elekta Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340201501634 [Direct Marking]
GS1	07340201501641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190887

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

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: 2024-06-28
• Device Publish Date: 2024-06-20

On-Brand Devices [Leksell Vantage Stereotactic System]

• 07340201502198: Leksell Vantage™ Head Frame
• 07340201501825: Leksell Vantage™ Head Frame
• 07340201501764: LEKSELL VANTAGE FRAME HOLDER
• 07340201501832: MRI FIDUCIAL BOX
• 07340201501535: Leksell Vantage™ Arc Tray
• 07340201501382: LEKSELL VANTAGE CT FIDUCIAL BOX
• 07340048306065: FirmFix™ Ruler
• 07340201501757: LEKSELL VANTAGE CT INTERFACE
• 07340201501719: Vantage™ Frame Holder extension
• 07340201501658: VANTAGE STARBURST 3/8
• 07340201501634: VANTAGE RADIOLUCENT STARBURST 1/2"
• 07340201501276: FirmFix™ 2
• 07340201501252: FirmFix™ 1