TRIA® II Display Doppler with 8.0 MHz Sterilizable Vascular Probe

GUDID 00888937019858

TRIA® II Display Doppler with 8.0 MHz Sterilizable Vascular Probe

Coopersurgical, Inc.

Noninvasive vascular ultrasound system, battery-powered

• Primary Device ID: 00888937019858
• NIH Device Record Key: 1b5bd2f7-00b2-496b-98d7-f82cb11396d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRIA® II Display Doppler with 8.0 MHz Sterilizable Vascular Probe
• Version Model Number: DMT337-DS
• Company DUNS: 801895244
• Company Name: Coopersurgical, Inc.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937019858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991441

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-04

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