Agility™

GUDID 05060191071031

Agility

ELEKTA LIMITED

Automatic-aperture-control accelerator system collimator

• Primary Device ID: 05060191071031
• NIH Device Record Key: 7c2d3709-3e58-4cbd-88e4-6840fe22fa0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Agility™
• Version Model Number: 1525725
• Company DUNS: 525557559
• Company Name: ELEKTA LIMITED
• 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: 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: +1(855)693-5358
• Email: systems.support.na@elekta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060191071031 [Primary]

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by ELEKTA LIMITED

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• 05060191071482 - Elekta Unity: 2021-12-08 Indexing Bar
• 05060191071499 - Elekta Unity: 2021-12-08 Indexing Bars
• 05060191071598 - Elekta Unity: 2021-12-08 Elekta Unity
• 05060191071345 - Integrity™: 2020-01-20 Integrity
• 05060191071420 - Elekta Unity: 2019-05-08 INDEXING BAR
• 05060191071437 - Elekta Unity: 2019-05-08 INDEXING BARS
• 05060191071321 - Elekta Unity: 2019-02-25 Elekta Unity