Leksell Stereotactic System Neurosurgical Instruments

GUDID 07340048311793

INSERTION RULER

Elekta Instrument AB

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 07340048311793
• NIH Device Record Key: ace932fc-fb13-4aed-bfd5-2140c85f82d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Stereotactic System Neurosurgical Instruments
• Version Model Number: 1075647
• Company DUNS: 507772663
• Company Name: Elekta Instrument AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340048311793 [Primary]

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: 2021-06-08
• Device Publish Date: 2021-05-31

Devices Manufactured by Elekta Instrument AB

• 07340048311892 - Leksell Vantage Stereotactic System: 2022-11-14 ARC CARRIER
• 07340048311793 - Leksell Stereotactic System Neurosurgical Instruments: 2021-06-08INSERTION RULER
• 07340048311793 - Leksell Stereotactic System Neurosurgical Instruments: 2021-06-08 INSERTION RULER
• 07340048312011 - Leksell Vantage Stereotactic System: 2021-04-07 MRI COIL ADAPTER UNIVERSAL
• 07340048311700 - Leksell Gamma Knife Perfexion/Icon: 2021-04-05 FILM HOLDER VANTAGE LGK
• 07340048311731 - Leksell Gamma Knife Perfexion/Icon: 2021-04-05 Dosimetry Phantom Vantage Base
• 07340048311755 - Leksell Gamma Knife Perfexion/Icon: 2021-04-05 QA TOOL VANTAGE LGK
• 07340048311762 - Leksell Gamma Knife Perfexion/Icon: 2021-04-05 Dosimetry Phantom Vantage LGK
• 07340048311779 - Leksell Gamma Knife Icon: 2021-04-05 LEKSELL VANTAGE ADAPTER LGK