ScanMed Elbow Coil

GUDID 00859193006319

SCANMED, LLC

MRI system coil, radio-frequency

• Primary Device ID: 00859193006319
• NIH Device Record Key: 90091e46-6de2-43f9-bc12-408b4e419ef1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScanMed Elbow Coil
• Version Model Number: 308SI3001
• 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	00859193006319 [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 Elbow Coil]

• 00859193006340: 316GE1501
• 00859193006319: 308SI3001
• 00859193006302: 308SI1501
• 00859193006296: 308GE3001
• 00859193006289: 308GE1501
• 00859193006593: 308GE1500