SICAT Air

GUDID B06965436510

HiCat GmbH

Diagnostic x-ray digital imaging system workstation

• Primary Device ID: B06965436510
• NIH Device Record Key: 3471e95a-c2e0-47f8-85fa-72e61810a1d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SICAT Air
• Version Model Number: 6543651
• Company DUNS: 312545378
• Company Name: HiCat GmbH
• 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: true
• Serial Number: false
• 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

Customer Support Contacts

• Phone: +496251161670
• Email: contact@sirona.com
• Phone: +496251161670
• Email: contact@sirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B06965436510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152661

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2019-02-21
• Device Publish Date: 2016-08-31