Leksell Gamma Knife C 4 4C

GUDID 07340048306638

Z SLIDES, LONG, SET OF TWO

Elekta Instrument AB

Teletherapy radionuclide system, conventional

• Primary Device ID: 07340048306638
• NIH Device Record Key: c29bf293-65b9-4205-b247-809c1197d9fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leksell Gamma Knife C 4 4C
• Version Model Number: 1500112
• Company DUNS: 507772663
• Company Name: Elekta Instrument AB
• Device Count: 2
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07340048306638 [Primary]
GS1	07340048306645 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984328

FDA Product Code

• IWB: System, radiation therapy, radionuclide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Leksell Gamma Knife C 4 4C]

• 07340048306638: Z SLIDES, LONG, SET OF TWO
• 07340048306607: Y/Z-SLIDES, STANDARD, SET OF TWO