Leksell Stereotactic System

GUDID 07340201502334

DISPOSABLE INSERTS 4 PCS

Elekta Solutions AB

Neurological stereotactic surgery system

• Primary Device ID: 07340201502334
• NIH Device Record Key: 21124e54-2400-48d7-85a5-6aef052af399
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Stereotactic System
• Version Model Number: 1040153
• Company DUNS: 353272181
• Company Name: Elekta Solutions AB
• Device Count: 4
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340201502334 [Unit of Use]
GS1	07340201502594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152558

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

[07340201502334]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-20
• Device Publish Date: 2025-02-12

Devices Manufactured by Elekta Solutions AB

• 07340201502334 - Leksell Stereotactic System: 2025-02-20DISPOSABLE INSERTS 4 PCS
• 07340201502334 - Leksell Stereotactic System: 2025-02-20 DISPOSABLE INSERTS 4 PCS
• 07340201501528 - Leksell Vantage Stereotactic System: 2024-12-09 Leksell Vantage Key
• 07340201501504 - Leksell Vantage Stereotactic System: 2024-12-09 Leksell Vantage™ Support Arc
• 07340201502129 - Leksell Vantage Stereotactic System: 2024-12-09 LEKSELL VANTAGE CARRIER
• 07340201501511 - Leksell Vantage Stereotactic System: 2024-09-09 LEKSELL VANTAGE ARC SYSTEM
• 07340201501887 - Leksell Vantage Stereotactic System: 2024-08-22 LEKSELL VANTAGE ARC SYSTEM
• 07340201501337 - Leksell Vantage Stereotactic System: 2024-08-14 FirmFix™ 5
• 07340201501290 - Leksell Vantage Stereotactic System: 2024-08-13 FirmFix™ 3