FLUOCASE 800

GUDID B475FC800CLV190

FLUOPTICS

Stationary general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: B475FC800CLV190
• NIH Device Record Key: a040a985-d4cd-4bf2-aad1-4c6f7f32b075
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLUOCASE 800
• Version Model Number: FC800-CL v1.9
• Company DUNS: 260631677
• Company Name: FLUOPTICS
• 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
HIBCC	B475FC800CLV190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132475

FDA Product Code

• OWN: Confocal Optical Imaging

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: 2018-07-26
• Device Publish Date: 2018-06-25

On-Brand Devices [FLUOCASE 800]

• B475FC800CLV190: FC800-CL v1.9
• B475FC800CLV180: FC800-CL v1.8