16ch Tx/Rx Knee SPEEDER Coil

GUDID 00814848020645

QUALITY ELECTRODYNAMICS LLC

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

• Primary Device ID: 00814848020645
• NIH Device Record Key: 299ca91b-04e5-4dc7-8a04-41b1975d9a58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 16ch Tx/Rx Knee SPEEDER Coil
• Version Model Number: Q7000160
• 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	00814848020645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161193

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: 2017-01-07

On-Brand Devices [16ch Tx/Rx Knee SPEEDER Coil]

• 00814848020645: Q7000160
• 00814848020591: Q7000147