LELTEK

GUDID 04719882150074

LELTEK INC.

General-purpose ultrasound imaging system

• Primary Device ID: 04719882150074
• NIH Device Record Key: b52e35c7-aab5-404a-8c54-b1baf94a90de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LELTEK
• Version Model Number: LU710M
• Company DUNS: 656116467
• Company Name: LELTEK 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: true
• 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	04719882150074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210432

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: 2022-11-03
• Device Publish Date: 2022-10-26

Devices Manufactured by LELTEK INC.

• 04719882150074 - LELTEK: 2022-11-03
• 04719882150074 - LELTEK: 2022-11-03
• 04719882152054 - ASUS: 2021-08-19
• 04719882152061 - ASUS: 2021-08-19
• 04719882150067 - LeSono: 2021-02-04
• 04719882151019 - Norland at Swissray: 2021-02-04
• 04719882151026 - Norland at Swissray: 2021-02-04
• 04719882150043 - LeSono: 2021-01-26
• 04719882150050 - LeSono: 2021-01-26