GEHC 1.5T Adult Head and Spine Array

GUDID 00859193006029

SCANMED, LLC

MRI system coil, radio-frequency

• Primary Device ID: 00859193006029
• NIH Device Record Key: 347e2fb1-bd6f-4688-aec3-f35a1dbf9573
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEHC 1.5T Adult Head and Spine Array
• Version Model Number: E8800HS
• 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	00859193006029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060689

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

Devices Manufactured by SCANMED, LLC

• 00859193006678 - ScanMed Hand/Wrist Coil: 2023-02-09
• 00859193006593 - ScanMed Elbow Coil: 2021-04-20
• 00859193006579 - ScanMed Orbit and Mandible Coil: 2020-03-05
• 00859193006005 - ScanMed PROCURE™ Coil: 2020-03-05
• 00859193006012 - GEHC 1.5T Pediatric Head and Spine Array: 2020-03-05
• 00859193006029 - GEHC 1.5T Adult Head and Spine Array: 2020-03-05
• 00859193006029 - GEHC 1.5T Adult Head and Spine Array: 2020-03-05
• 00859193006036 - ScanMed Knee/Foot Coil: 2020-03-05
• 00859193006043 - ScanMed Knee/Foot Coil: 2020-03-05