CLISIS SYSTEMS

GUDID 08054890480093

The ceiling suspension is a radiographic X-ray tube suspension device that allows direct digital radiological diagnostic, pulmonary, skeletal and emergency.

GENERAL MEDICAL MERATE SPA

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• Primary Device ID: 08054890480093
• NIH Device Record Key: 1a6375d4-6bc6-41a4-8a78-fdad437a46b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLISIS SYSTEMS
• Version Model Number: KALOS
• Company DUNS: 428658934
• Company Name: GENERAL MEDICAL MERATE SPA
• 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	08054890480093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173395
• Premarket Notification: K213081

FDA Product Code

• IYB: Tube Mount, X-Ray, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-10
• Device Publish Date: 2018-07-11

On-Brand Devices [CLISIS SYSTEMS]

• 08054890480093: The ceiling suspension is a radiographic X-ray tube suspension device that allows direct digital
• 08054890480086: The wall bucky stand is used to perform exposures on the potter-bucky.
• 08054890480079: It's a system for acquiring digital images in fluoroscopy and radiography modes from a solid sta
• 08054890480062: It is an R&F remote controlled table, that can be used as a traditional R&F remote tilting table
• 08054890480055: CLISIS SYSTEMS is a system indicated for performing general radiography, fluoroscopy and angiogr