Cellvizio® 100 series (488nm) CS-100-448-CK-1

GUDID 00827002472693

MAUNA KEA TECHNOLOGIES

Confocal endomicroscopy system

• Primary Device ID: 00827002472693
• NIH Device Record Key: c58b7028-85e0-4f98-adf3-94317e682bd4
• Commercial Distribution Discontinuation: 2020-04-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Cellvizio® 100 series (488nm)
• Version Model Number: 210-0027
• Catalog Number: CS-100-448-CK-1
• Company DUNS: 394136118
• Company Name: MAUNA KEA TECHNOLOGIES
• 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	00827002472693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111047

FDA Product Code

• OWN: Confocal Optical 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: 4
• Public Version Date: 2020-05-07
• Device Publish Date: 2016-12-12

On-Brand Devices [Cellvizio® 100 series (488nm)]

• 00827002472716: 210-0027
• 00827002472693: 210-0027