LA2-9S

GUDID 08809725815041

SAMSUNG MEDISON CO., LTD.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 08809725815041
• NIH Device Record Key: 25dbc63e-3b71-444e-a678-47d5b3239412
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LA2-9S
• Version Model Number: USP-L029NSA/WR
• Company DUNS: 687785691
• Company Name: SAMSUNG MEDISON CO., LTD.
• 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	08809725815041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220269

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: 2022-06-01
• Device Publish Date: 2022-05-24

Devices Manufactured by SAMSUNG MEDISON CO., LTD.

• 08800289979132 - cV4 Diagnostic Ultrasound System: 2025-09-11 cV4 Diagnostic Ultrasound System
• 08800289981883 - cV5 Diagnostic Ultrasound System: 2025-09-11
• 08806167766030 - LA3-16AD: 2025-09-11
• 08809702988614 - MMPT3-7: 2025-09-11
• 08809944884736 - TA2-9: 2025-09-11
• 08809944906476 - LM2-18D: 2025-09-11
• 08809944935292 - MMPT3-7: 2025-09-11
• 08809944942450 - miniER7: 2025-09-11