Leksell Gamma Knife Esprit

GUDID 07340201501139

Elekta Esprit

Elekta Solutions AB

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• Primary Device ID: 07340201501139
• NIH Device Record Key: f07ed625-081f-4ca0-a62c-84df9ce58627
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Gamma Knife Esprit
• Version Model Number: 1110200
• 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

Customer Support Contacts

• Phone: 8556935358
• Email: info.america@elekta.com
• Phone: 8556935358
• Email: info.america@elekta.com
• Phone: 8556935358
• Email: info.america@elekta.com
• Phone: 8556935358
• Email: info.america@elekta.com
• Phone: 8556935358
• Email: info.america@elekta.com
• Phone: 8556935358
• Email: info.america@elekta.com
• Phone: 8556935358
• Email: info.america@elekta.com
• Phone: 8556935358
• Email: info.america@elekta.com
• Phone: 8556935358
• Email: info.america@elekta.com
• Phone: 8556935358
• Email: info.america@elekta.com
• Phone: 8556935358
• Email: info.america@elekta.com
• Phone: 8556935358
• Email: info.america@elekta.com
• Phone: 8556935358
• Email: info.america@elekta.com
• Phone: 8556935358
• Email: info.america@elekta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340201501139 [Primary]

FDA Product Code

• IWB: System, Radiation Therapy, Radionuclide

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: 2023-04-04
• Device Publish Date: 2023-03-27

Devices Manufactured by Elekta Solutions AB

• 07340201500057 - ProKnow DS: 2024-03-29
• 07340201502136 - Leksell GammaPlan: 2024-02-22 Leksell GammaPlan
• 07540180000221 - Clarity®: 2023-06-30 Clarity® Software
• 07340201500064 - Monaco: 2023-04-12
• 07340201500071 - MOSAIQ: 2023-04-12
• 07340201501139 - Leksell Gamma Knife Esprit: 2023-04-04Elekta Esprit
• 07340201501139 - Leksell Gamma Knife Esprit: 2023-04-04 Elekta Esprit
• 07340201500033 - Monaco: 2022-07-19
• 07340201500040 - AATMA: 2022-03-17