Elekta Medical Linear Accelerator

GUDID 05060191071581

Elekta Harmony

Elekta Solutions AB

Linear accelerator system

• Primary Device ID: 05060191071581
• NIH Device Record Key: 711233ee-cc8e-495a-961a-50a86630423a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elekta Medical Linear Accelerator
• Version Model Number: 1553032
• Company DUNS: 353272181
• Company Name: Elekta Solutions 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: 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
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com
• Phone: +1(855)693-5358
• Email: systems.support.na@elekta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060191071581 [Primary]

FDA Product Code

• IYE: Accelerator, linear, medical

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: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [Elekta Medical Linear Accelerator]

• 05060191071604: Elekta Harmony Pro
• 05060191071581: Elekta Harmony
• 05060191071574: Versa HD™
• 05060191071550: Elekta Synergy®
• 05060191071543: Elekta Infinity™
• 05060191071529: Versa HD™
• 05060191071512: Elekta Infinity™
• 05060191071505: Elekta Synergy®