16ch T/R Hand Wrist Coil

GUDID 00814848020782

QUALITY ELECTRODYNAMICS LLC

MRI system coil, radio-frequency

• Primary Device ID: 00814848020782
• NIH Device Record Key: 343d166f-267a-47bb-a853-5c669d1cf6d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 16ch T/R Hand Wrist Coil
• Version Model Number: Q7000238
• 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	00814848020782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173469

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: 2024-07-26
• Device Publish Date: 2024-07-18

On-Brand Devices [16ch T/R Hand Wrist Coil]

• 00814848020485: Q7000152
• 00814848020249: Q7000180
• 00814848020782: Q7000238