ScanMed Knee/Foot Coil

GUDID 00859193006043

SCANMED, LLC

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

• Primary Device ID: 00859193006043
• NIH Device Record Key: 5b3e4c77-18b2-4bf3-b1cd-e408fe3659e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScanMed Knee/Foot Coil
• Version Model Number: 108GE3001
• Company DUNS: 080151631
• Company Name: SCANMED, 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: false
• 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	00859193006043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130457

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: 2017-01-12

On-Brand Devices [ScanMed Knee/Foot Coil]

• 00859193006104: 116SI3001
• 00859193006098: 116SI1501
• 00859193006081: 116GE3001
• 00859193006074: 116GE1501
• 00859193006067: 108SI3001
• 00859193006050: 108SI1501
• 00859193006043: 108GE3001
• 00859193006036: 108GE1501