GUDID 00840682118989

Hangwei GE Medical Systems Co., Ltd.

MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency MRI system coil, radio-frequency

• Primary Device ID: 00840682118989
• NIH Device Record Key: 642535df-c3b0-48bd-9f16-422535599af9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: EXPRESS COIL - ANTERIOR ARRAY
• Company DUNS: 654659689
• Company Name: Hangwei GE Medical Systems Co., Ltd.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682118989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103330

FDA Product Code

• LNI: System, nuclear magnetic resonance spectroscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2016-08-01

Devices Manufactured by Hangwei GE Medical Systems Co., Ltd.

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• 00195278788665 - Revolution Apex: 2024-01-03 Revolution Apex Select with Plus Edition - Designated System Medical Device
• 00195278526892 - Definium: 2023-09-26 Definium Pace Select system designated medical device
• 00195278713759 - NA: 2023-09-26 Galaxy 2.0 Wall Stand
• 00195278713766 - NA: 2023-09-26 Value Fixed Table
• 00195278686718 - Revolution: 2023-06-30 Revolution Maxima CT designated medical device
• 00195278524904 - Optima: 2022-10-28 Optima IGS Ultra UDI
• 00195278524911 - Optima: 2022-10-28 Optima IGS Mega UDI