Visura TEECAD Carrier VIS0100

GUDID 00860226002529

Visura TEECAD Carrier

VISURA TECHNOLOGIES, INC.

Ultrasound imaging transducer positioning unit

• Primary Device ID: 00860226002529
• NIH Device Record Key: a8037668-3775-4f3f-baf7-2fb5bf58d451
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Visura TEECAD Carrier
• Version Model Number: CR-P2
• Catalog Number: VIS0100
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	00860226002505 [Previous]
GS1	00860226002529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180911

FDA Product Code

• FDS: Gastroscope And Accessories, Flexible/Rigid

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: 2022-08-03Visura TEECAD Carrier
• 00860226002529 - Visura TEECAD Carrier: 2022-08-03 Visura TEECAD Carrier
• 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