Leksell Stereotactic System 1040320

GUDID 07340201503294

Leksell MPS Arc w Counter Scale - ARC WITH SUPPORT LEFT

Elekta Solutions AB

Neurological stereotactic surgery system

• Primary Device ID: 07340201503294
• NIH Device Record Key: 2aa337cc-61d2-4067-abf4-1b163d201453
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Stereotactic System
• Version Model Number: 1040432
• Catalog Number: 1040320
• Company DUNS: 353272181
• Company Name: Elekta Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340201503294 [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

[07340201503294]

Moist Heat or Steam Sterilization

[07340201503294]

Moist Heat or Steam Sterilization

[07340201503294]

Moist Heat or Steam Sterilization

[07340201503294]

Moist Heat or Steam Sterilization

[07340201503294]

Moist Heat or Steam Sterilization

[07340201503294]

Moist Heat or Steam Sterilization

[07340201503294]

Moist Heat or Steam Sterilization

[07340201503294]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-25
• Device Publish Date: 2025-09-17

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
• 07340201502754: FIXATION SCREW 65 MM, TITANIUM
• 07340201502655: FIXATION SCREW 30 MM, TITANIUM
• 07340201502631: FIXATION SCREW 25 MM, TITANIUM
• 07340201502600: FIXATION SCREW 20 MM, TITANIUM
• 07340201502815: Sterilization Case Fixation Screws
• 07340201502662: FIXATION SCREW 32,5 MM, TITANIUM
• 07340201503492: TITANIUM FIXATION SCREW, KIT 20 PAIRS
• 07340201502808: FIXATION SCREW 110 MM, TITANIUM
• 07340201502792: FIXATION SCREW 90 MM, TITANIUM
• 07340201502785: FIXATION SCREW 80 MM, TITANIUM
• 07340201502778: FIXATION SCREW 75 MM, TITANIUM
• 07340201502761: FIXATION SCREW 70 MM, TITANIUM
• 07340201502747: FIXATION SCREW 60 MM, TITANIUM
• 07340201502730: FIXATION SCREW 55 MM, TITANIUM
• 07340201502723: FIXATION SCREW 50 MM, TITANIUM
• 07340201502709: FIXATION SCREW 42,5 MM, TITANIUM
• 07340201502686: FIXATION SCREW 37,5 MM, TITANIUM
• 07340201503126: OPEN MR-INDICATOR - PLATE LEFT
• 07340201502969: OPEN MR-INDICATOR - PLATE HOLDER
• 07340201502952: OPEN MR-INDICATOR - PLATE RIGHT
• 07340201502617: CT-Adapter, Adjustable
• 07340201502327: CROSS HAIR TARGET, STAINLESS - ingoing part CROSS HAIR TARGET CROSS
• 07340201502310: CROSS HAIR TARGET, STAINLESS - ingoing part CROSS HAIR TARGET RING
• 07340201502303: CROSS HAIR TARGET, STAINLESS
• 07340201503454: Ear Plug Holders - ATTACHMENT, EAR PLUG LEFT
• 07340201503331: MR Phantom
• 07340201503300: Leksell MPS Arc w Counter Scale - ARC SLIDE RIGHT
• 07340201503294: Leksell MPS Arc w Counter Scale - ARC WITH SUPPORT LEFT
• 07340201503249: Leksell Coordinate Frame G - STRAIGHT FRONT PIECE
• 07340201503232: X-RAY INDICATOR WITH MARKERS - COVER
• 07340201503225: X-RAY INDICATOR WITH MARKERS
• 07340201503201: Leksell MPS Arc w Counter Scale - ARC CARRIER
• 07340201503195: Leksell MPS Arc w Counter Scale - ARC ENGRAVED
• 07340201503188: Leksell MPS Arc w Counter Scale - ARC ATTACHMENT WITH INDEX
• 07340201503171: Leksell MPS Arc w Counter Scale - ARC STOP SLIDE