Integrity™

GUDID 05060191071345

Integrity

ELEKTA LIMITED

Linear accelerator system

• Primary Device ID: 05060191071345
• NIH Device Record Key: dd8a1492-6bfd-45b4-8c7c-6bd5b3c7ec84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integrity™
• Version Model Number: 1537146
• 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: true
• 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: systems.support.na@elekta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060191071345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182138

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: 3
• Public Version Date: 2020-01-20
• Device Publish Date: 2018-11-02

On-Brand Devices [Integrity™]

• 05060191071345: Integrity
• 05060191071079: Integrity
• 05060191071062: Integrity