Visura TEECAD Carrier Control Unit VIS0101

GUDID 00860226002536

Visura TEECAD Carrier Control Unit

VISURA TECHNOLOGIES, INC.

Ultrasound imaging transducer positioning unit

• Primary Device ID: 00860226002536
• NIH Device Record Key: aa69e9cf-f3c7-456c-9326-12bfb0cec6e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visura TEECAD Carrier Control Unit
• Version Model Number: VS-V2
• Catalog Number: VIS0101
• Company DUNS: 117057841
• Company Name: VISURA TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: (651) 236-9226
• Email: quality@visuratechnologies.com
• Phone: (651) 236-9226
• Email: quality@visuratechnologies.com
• Phone: (651) 236-9226
• Email: quality@visuratechnologies.com
• Phone: (651) 236-9226
• Email: quality@visuratechnologies.com
• Phone: (651) 236-9226
• Email: quality@visuratechnologies.com
• Phone: (651) 236-9226
• Email: quality@visuratechnologies.com
• Phone: (651) 236-9226
• Email: quality@visuratechnologies.com
• Phone: (651) 236-9226
• Email: quality@visuratechnologies.com
• Phone: (651) 236-9226
• Email: quality@visuratechnologies.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860226002512 [Previous]
GS1	00860226002536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180911

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

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: 2022-08-03
• Device Publish Date: 2022-07-26

Devices Manufactured by VISURA TECHNOLOGIES, INC.

• 00860226002529 - Visura TEECAD Carrier: 2022-08-03 Visura TEECAD Carrier
• 00860226002536 - Visura TEECAD Carrier Control Unit: 2022-08-03Visura TEECAD Carrier Control Unit
• 00860226002536 - Visura TEECAD Carrier Control Unit: 2022-08-03 Visura TEECAD Carrier Control Unit
• 00860226002505 - TEECAD: 2019-07-15 TEECAD Carrier - PX72T
• 00860226002512 - TEECAD: 2019-07-15 TEECAD Viewing System