Precision

GUDID 00840682120982

GE MEDICAL SYSTEMS, INC.

Stationary general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 00840682120982
• NIH Device Record Key: 57960062-13b3-42fb-a45c-c9e3d34bbedb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision
• Version Model Number: 600FP
• 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: 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	00840682120982 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133553

FDA Product Code

• JAA: System, x-ray, fluoroscopic, image-intensified

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-01

On-Brand Devices [Precision]

• 00840682120982: 600FP
• 00840682119238: 500D