AMX

GUDID 00195278003348

AMX Navigate Designated Medical Device Assembly

GE MEDICAL SYSTEMS, INC.

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• Primary Device ID: 00195278003348
• NIH Device Record Key: fbbcf95c-ddec-4fc6-8b0a-8563e93c4c9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMX
• Version Model Number: Navigate
• Company DUNS: 809785715
• Company Name: GE MEDICAL SYSTEMS, 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: true
• 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	00195278003348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210982

FDA Product Code

• IZL: System, x-ray, mobile

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-01
• Device Publish Date: 2021-10-22

On-Brand Devices [AMX]

• 00195278003348: AMX Navigate Designated Medical Device Assembly
• 00195278798374: AMX Navigate Upgrade Designated Medical Device Assembly