Kosmos Torso-One - USB

GUDID 09353278000571

Ultrasound imaging transducer, hand-held

ECHONOUS, INC.

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• Primary Device ID: 09353278000571
• NIH Device Record Key: 7733d880-2325-41b3-9f7a-236b2bb7ac8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kosmos Torso-One - USB
• Version Model Number: R006632
• Company DUNS: 080481089
• Company Name: ECHONOUS, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09353278000571 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193518

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: 2021-11-04
• Device Publish Date: 2021-10-27

On-Brand Devices [Kosmos Torso-One - USB]

• 09353278000502: P006632
• 09353278000571: Ultrasound imaging transducer, hand-held