Leksell Gamma Knife Icon

GUDID 07340048311779

LEKSELL VANTAGE ADAPTER LGK

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: 07340048311779
• NIH Device Record Key: 6421045a-f112-427d-adb1-6552d3796b47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Gamma Knife Icon
• Version Model Number: 1075251
• 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: true
• 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	07340048311779 [Direct Marking]
GS1	07340048311786 [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 Icon]

• 07340048304917: PATIENT MARKERS (10 PCS)
• 07340048306584: QA+ TOOL
• 07340048306577: MR HEAD SUPPORT PERFEXION
• 07340048306560: MR PHILIPS INTERFACE
• 07340048305624: PHANTOM BASE PLATE
• 07340048305587: LEKSELL GAMMA KNIFE ICON
• 07340048304962: MR HEAD SUPPORT PERFEXION
• 07340048304955: MASK ADAPTER ASM
• 07340048304924: PATIENT MARKERS (10 PCS)
• 07340048304634: LGK MASKS EFFICAST (1 PCS)
• 07340048304610: LGK MASK NANOR (1 PCS)
• 07340048304566: ICON PATIENT CUSION KLARITY
• 07340048311779: LEKSELL VANTAGE ADAPTER LGK