TEECAD

GUDID 00860226002512

TEECAD Viewing System

VISURA TECHNOLOGIES, INC.

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• Primary Device ID: 00860226002512
• NIH Device Record Key: 93999efb-8562-4c33-8987-4acd9b5b4f47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEECAD
• Version Model Number: VS-V1
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860226002512 [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: 2019-07-15
• Device Publish Date: 2019-07-06

On-Brand Devices [TEECAD]

• 00860226002512: TEECAD Viewing System
• 00860226002505: TEECAD Carrier - PX72T