Contour Shoulder

GUDID 00814848020799

QUALITY ELECTRODYNAMICS LLC

MRI system coil, radio-frequency

• Primary Device ID: 00814848020799
• NIH Device Record Key: a86e4dd2-2832-4f2f-af43-0cc0e64d4cc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contour Shoulder
• Version Model Number: Q7000222
• 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	00814848020799 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233656

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-11
• Device Publish Date: 2025-04-03

Devices Manufactured by QUALITY ELECTRODYNAMICS LLC

• 00814848020812 - 16ch Flex SPEEDER Medium 1.5T: 2025-05-28
• 00814848020829 - 16ch Flex SPEEDER Large 1.5T: 2025-05-28
• 00814848020775 - SureWave Elastography: 2025-04-21
• 00814848020799 - Contour Shoulder: 2025-04-11
• 00814848020799 - Contour Shoulder: 2025-04-11
• 00814848020782 - 16ch T/R Hand Wrist Coil: 2024-07-26
• 00814848020508 - Shape Coil: 2021-08-30
• 00814848020546 - Shape Coil: 2021-08-30
• 00814848020515 - 2Tx 28Rx Knee Coil: 2021-02-22