TxRx Knee 15 Flare MR Coil

GUDID 00814848020676

QUALITY ELECTRODYNAMICS LLC

MRI system coil, radio-frequency

• Primary Device ID: 00814848020676
• NIH Device Record Key: 9e370e33-88c0-4779-a05d-27dfa9ab9228
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TxRx Knee 15 Flare MR Coil
• Version Model Number: Q7000168
• 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	00814848020676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163066

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: 2016-12-17

On-Brand Devices [TxRx Knee 15 Flare MR Coil]

• 00814848020676: Q7000168
• 00814848020669: Q7000167