GUDID 00853704006010

ALLTECH MEDICAL SYSTEMS AMERICA, INC.

Full-body MRI system, superconducting magnet

• Primary Device ID: 00853704006010
• NIH Device Record Key: 8131ad58-4b20-4f8e-ba2d-457ad411ab21
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Comfort EC710
• Company DUNS: 828375696
• Company Name: ALLTECH MEDICAL SYSTEMS AMERICA, INC.
• 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	00853704006010 [Primary]

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-17

Devices Manufactured by ALLTECH MEDICAL SYSTEMS AMERICA, INC.

• 00853704006003 - NA: 2018-03-29
• 00853704006010 - NA: 2018-03-29
• 00853704006010 - NA: 2018-03-29