Leksell Stereotactic System 1040318

GUDID 07340201503263

FRAME G

Elekta Solutions AB

Neurological stereotactic surgery system

• Primary Device ID: 07340201503263
• NIH Device Record Key: 31d4eb96-d93f-411d-87e2-351f201adfa6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Stereotactic System
• Version Model Number: 1040455
• Catalog Number: 1040318
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340201503263 [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: false

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

[07340201503263]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-11
• Device Publish Date: 2025-07-03

On-Brand Devices [Leksell Stereotactic System]

• 07340201502334: DISPOSABLE INSERTS 4 PCS
• 07340201502341: OPEN MR-INDICATOR
• 07340201503263: FRAME G
• 07340201502297: STERILIZING TRAY FOR G FRAME KIT