Ingenia Elition S

GUDID 00884838088108

Magnetic Resonance Equipment

Philips Medical Systems Nederland B.V.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00884838088108
• NIH Device Record Key: 3214e84a-3853-400b-a8a5-c6c83f563cb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ingenia Elition S
• Version Model Number: 781357
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838088108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173356
• Premarket Notification: K173451
• Premarket Notification: K183063

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

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: 2019-05-03
• Device Publish Date: 2018-05-01

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