GUDID 00840682115896

USA INSTRUMENTS, INC.

MRI system coil, radio-frequency

• Primary Device ID: 00840682115896
• NIH Device Record Key: 6cb79f73-167f-4ef9-b588-ad2551baf1b9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 1.5T GEM RT Open Array
• Company DUNS: 804517571
• Company Name: USA INSTRUMENTS, 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682115896 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123327

FDA Product Code

• MOS: Coil, magnetic resonance, specialty

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 USA INSTRUMENTS, INC.

• 00195278665249 - NA: 2023-08-11 48CH HEAD COIL - POSTERIOR
• 00195278575814 - NA: 2023-07-05 3.0T 16ch AIR AA
• 00840682108867 - NA: 2020-03-05
• 00840682114387 - NA: 2020-03-05
• 00840682114394 - NA: 2020-03-05
• 00840682114400 - NA: 2020-03-05
• 00840682114547 - NA: 2020-03-05
• 00840682115780 - NA: 2020-03-05