Kosmos

GUDID 09353278000847

MENDAERA 210-00160: PACKAGED LINEAR LEXSA PROBE

ECHONOUS, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 09353278000847
• NIH Device Record Key: 20827906-68de-4eb3-b86d-8a635b97c707
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kosmos
• Version Model Number: P008041
• Company DUNS: 080481089
• Company Name: ECHONOUS, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09353278000847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212100

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

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: 2025-08-18
• Device Publish Date: 2025-08-08

On-Brand Devices [Kosmos]

• 09353278000847: MENDAERA 210-00160: PACKAGED LINEAR LEXSA PROBE
• 09353278000830: MENDAERA 210-00161: PACKAGED TORSO-ONE USB PROBE