CRUXCAN CRX-1000

GUDID 08800049600016

CRUXELL Corp

Dental computed radiography digital imaging scanner

• Primary Device ID: 08800049600016
• NIH Device Record Key: 7ebb4dea-9e5c-46e2-829a-b56f470cb970
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRUXCAN
• Version Model Number: CRX-1000
• Catalog Number: CRX-1000
• Company DUNS: 694772082
• Company Name: CRUXELL Corp
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800049600016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183637

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

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: 2019-04-23
• Device Publish Date: 2019-04-15