TxRx CP Head Coil

GUDID 00814848020393

QUALITY ELECTRODYNAMICS LLC

MRI system coil, radio-frequency

• Primary Device ID: 00814848020393
• NIH Device Record Key: 123b30d1-25c2-479b-8a60-5fc854f66794
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TxRx CP Head Coil
• Version Model Number: Q7000060
• Company DUNS: 614760119
• Company Name: QUALITY ELECTRODYNAMICS LLC
• 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	00814848020393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091114

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: 2016-09-16

On-Brand Devices [TxRx CP Head Coil]

• 00814848020393: Q7000060
• 00814848020379: Q7000059
• 00814848020164: Q7000027
• 00814848020140: Q7000026