Cios Select

GUDID 04056869148243

mobile C-arm; FD

Siemens Shanghai Medical Equipment Ltd.

Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital Portable general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 04056869148243
• NIH Device Record Key: ad7aadd6-6684-4bac-8217-c0fe8c46a747
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cios Select
• Version Model Number: 11020806
• Company DUNS: 654129626
• Company Name: Siemens Shanghai Medical Equipment Ltd.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056869148243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181767

FDA Product Code

• OWB: Interventional fluoroscopic x-ray system

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: 2019-10-07
• Device Publish Date: 2018-09-20

On-Brand Devices [Cios Select]

• 04056869148243: mobile C-arm; FD
• 04056869028132: mobile C-arm
• 04056869267180: 11515088
• 04056869267197: mobile C-arm; software version VA21