Leksell Stereotactic System

GUDID 07340201502907

Post Insulated posterior short

Elekta Solutions AB

Neurological stereotactic surgery system

• Primary Device ID: 07340201502907
• NIH Device Record Key: 7dc743c5-6383-4923-b5c4-b4ee9036060f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Stereotactic System
• Version Model Number: 1040312
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340201502464 [Primary]
GS1	07340201502907 [Direct Marking]

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

[07340201502907]

Moist Heat or Steam Sterilization

[07340201502907]

Moist Heat or Steam Sterilization

[07340201502907]

Moist Heat or Steam Sterilization

[07340201502907]

Moist Heat or Steam Sterilization

[07340201502907]

Moist Heat or Steam Sterilization

[07340201502907]

Moist Heat or Steam Sterilization

[07340201502907]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-12
• Device Publish Date: 2025-09-04

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
• 07340201502884: LEKSELL STEREOTACTIC SYSTEM CLAMP, Frame support, ingoing part of 1040304.
• 07340201502877: LEKSELL STEREOTACTIC SYSTEM CLAMP, Clamp Spacer, ingoing part of 1040304.
• 07340201502860: LEKSELL STEREOTACTIC SYSTEM CLAMP, Headrest support, ingoing part of 1040304.
• 07340201502280: LEKSELL STEREOTACTIC SYSTEM CLAMP
• 07340201503478: TITANIUM FIXATION SCREW, KIT 5 PAIRS
• 07340201502693: FIXATION SCREW 40 MM, TITANIUM
• 07340201502648: FIXATION SCREW 27,5 MM, TITANIUM
• 07340201502716: FIXATION SCREW 45 MM, TITANIUM
• 07340201502624: FIXATION SCREW 22,5 MM, TITANIUM
• 07340201502983: STERILIZING TRAY FOR MULTIPURPOSE ARC
• 07340201502907: Post Insulated posterior short