Leksell GammaPlan

GUDID 07340201502136

Leksell GammaPlan

Elekta Solutions AB

Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software Stereotactic system application software

• Primary Device ID: 07340201502136
• NIH Device Record Key: 61d2e8e0-c2b5-4549-a09d-296e80fecf04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell GammaPlan
• Version Model Number: 1567714
• Company DUNS: 353272181
• Company Name: Elekta Solutions 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: false
• 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: 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
• 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	07340201502136 [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: 2024-02-22
• Device Publish Date: 2024-02-14

Devices Manufactured by Elekta Solutions AB

• 07340201500057 - ProKnow DS: 2024-03-29
• 07340201502136 - Leksell GammaPlan: 2024-02-22Leksell GammaPlan
• 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: 2023-04-04 Elekta Esprit
• 07340201500033 - Monaco: 2022-07-19
• 07340201500040 - AATMA: 2022-03-17