Leksell Vantage Stereotactic System 1040036

GUDID 07340201501825

Leksell Vantage™ Head Frame

Elekta Solutions AB

Neurological stereotactic surgery system

• Primary Device ID: 07340201501825
• NIH Device Record Key: 6721aabe-d57b-4f9f-8da6-0d39e297cecc
• Commercial Distribution Discontinuation: 2024-06-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Leksell Vantage Stereotactic System
• Version Model Number: 1040036
• Catalog Number: 1040036
• Company DUNS: 353272181
• Company Name: Elekta Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com
• Phone: +1(855)693-5358
• Email: info.america@elekta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340201501825 [Direct Marking]
GS1	07340201501849 [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: 2024-06-19
• Device Publish Date: 2024-06-11

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
• 07340201501313: FirmFix™ 4
• 07340201501290: FirmFix™ 3
• 07340201501337: FirmFix™ 5
• 07340201501887: LEKSELL VANTAGE ARC SYSTEM
• 07340201501511: LEKSELL VANTAGE ARC SYSTEM