Sonosite ST P31203

GUDID 00841517109233

Sonosite ST Stand Head

FUJIFILM SONOSITE, INC.

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• Primary Device ID: 00841517109233
• NIH Device Record Key: 6ba1f804-155e-4a26-b150-fc5fd98359d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonosite ST
• Version Model Number: P31203-20
• Catalog Number: P31203
• Company DUNS: 014438860
• Company Name: FUJIFILM SONOSITE, 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	00841517109233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213763

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: 2023-06-01
• Device Publish Date: 2023-05-24

On-Brand Devices [Sonosite ST ]

• 00841517109233: Sonosite ST Stand Head
• 00841517109219: Sonosite ST Ultrasound System
• 00841517110055: Sonosite ST Stand
• 00841517110048: Diagnostic ultrasound system
• 00841517110567: Sonosite ST
• 00841517110550: SONOSITE ST ULTRASOUND SYSTEM, 1.1, UKCA
• 00841517110543: SONOSITE ST ULTRASOUND SYSTEM, 1.0