PA1-5A

GUDID 08806167759674

SAMSUNG MEDISON CO., LTD.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 08806167759674
• NIH Device Record Key: d8e73fef-2d52-417a-b341-c9df311c0928
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PA1-5A
• Version Model Number: USP-P015FSA/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	08806167759674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170493

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: 2020-05-06
• Device Publish Date: 2020-04-28

On-Brand Devices [PA1-5A]

• 08806167759674: USP-P015FSA/WR
• 08809702986450: USP-P015FSB/WR