Optima

GUDID 00840682102513

GE Holdings Luxembourg & Co SARL

Full-body CT system

• Primary Device ID: 00840682102513
• NIH Device Record Key: 891250fc-128a-49d2-af94-db1033b9a76d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optima
• Version Model Number: CT580
• Company DUNS: 400736245
• Company Name: GE Holdings Luxembourg & Co SARL
• 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	00840682102513 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093581

FDA Product Code

• JAK: System, x-ray, tomography, computed

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: 2016-06-08