8ch Knee SPEEDER Coil

GUDID 00814848020652

QUALITY ELECTRODYNAMICS LLC

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

• Primary Device ID: 00814848020652
• NIH Device Record Key: 41579b25-af88-45f4-bfb8-5b664c50d4e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8ch Knee SPEEDER Coil
• Version Model Number: Q7000166
• 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	00814848020652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152695

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

Devices Manufactured by QUALITY ELECTRODYNAMICS LLC

• 00814848020508 - Shape Coil: 2021-08-30
• 00814848020546 - Shape Coil: 2021-08-30
• 00814848020515 - 2Tx 28Rx Knee Coil: 2021-02-22
• 00814848020423 - Contour 24: 2020-03-05
• 00814848020003 - 18ch T/R Knee Coil: 2020-03-05
• 00814848020010 - Atlas SPEEDER Head/Neck Coil: 2020-03-05
• 00814848020027 - Wrist SPEEDER Coil: 2020-03-05
• 00814848020034 - Tx/Rx Extra Large Knee Coil: 2020-03-05