Leksell Gamma Knife Perfexion/Icon

GUDID 07340048311731

Dosimetry Phantom Vantage Base

Elekta Instrument AB

Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional Teletherapy radionuclide system, conventional

• Primary Device ID: 07340048311731
• NIH Device Record Key: 9e6ff044-2a4e-45cf-ad88-d8d076d07e46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Gamma Knife Perfexion/Icon
• Version Model Number: 1075233
• 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: false
• 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
• 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	07340048311731 [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: 2021-04-05
• Device Publish Date: 2021-03-28

On-Brand Devices [Leksell Gamma Knife Perfexion/Icon]

• 07340048309516: FRAME FIXATION ADAPTER
• 07340048307963: FRAME FIXATION ADAPTER
• 07340048306591: CC EXCHANGE TOOL
• 07340048306553: CLEARENCE CHECK TOOL
• 07340048306546: QA FILM HOLDER
• 07340048306522: FRAME CAP
• 07340048306454: DOSIMETRY PHANTOM
• 07340048306188: RADIATION PHANTOM WITH CASSETTES
• 07340048305617: PHANTOM ADAPTER COMPLETE
• 07340048306447: LEKSELL GAMMA KNIFE DOSIMETRY PHANTOM
• 07340048305112: POST INSULATED LONG POSTERIOR
• 07340048311762: Dosimetry Phantom Vantage LGK
• 07340048311755: QA TOOL VANTAGE LGK
• 07340048311731: Dosimetry Phantom Vantage Base
• 07340048311700: FILM HOLDER VANTAGE LGK