MOSAIQ

GUDID 00858164002251

ELEKTA, INC.

Patient health record information system application software

• Primary Device ID: 00858164002251
• NIH Device Record Key: 12a3b55c-3013-4bdb-90c9-4fe0b9908897
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOSAIQ
• Version Model Number: MOSAIQ
• Company DUNS: 080819146
• Company Name: ELEKTA, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858164002251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183034

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: 2019-08-12
• Device Publish Date: 2018-12-20

On-Brand Devices [MOSAIQ]

• 00858164002251: MOSAIQ
• 00858164002237: MOSAIQ
• 00858164002220: MOSAIQ
• 00858164002091: MOSAIQ
• 00858164002282: MOSAIQ
• 00858164002336: MOSAIQ
• 00858164002367: MOSAIQ