ScanMed PROCURE™ Coil

GUDID 00859193006425

SCANMED, LLC

MRI system coil, radio-frequency

• Primary Device ID: 00859193006425
• NIH Device Record Key: debe3001-7a23-4d9a-9ae8-60d7906f50c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ScanMed PROCURE™ Coil
• Version Model Number: 588PH3001
• 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	00859193006425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140606

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: 2017-08-31

On-Brand Devices [ScanMed PROCURE™ Coil]

• 00859193006456: 508PH3001
• 00859193006449: 508PH1501
• 00859193006425: 588PH3001
• 00859193006371: 588PH1501
• 00859193006210: 588SI1501
• 00859193006203: 588GE3001
• 00859193006197: 588GE1501
• 00859193006142: 508SI3001
• 00859193006135: 508SI1501
• 00859193006128: 508GE3001
• 00859193006111: 508GE1501
• 00859193006005: 588SI3001