P10x/8-4 MHz P07696

GUDID 00841517108960

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517108960
• NIH Device Record Key: fe60eaf6-cf6d-424b-9bdb-9a3e4a296439
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P10x/8-4 MHz
• Version Model Number: P07696-81
• Catalog Number: P07696
• 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	00841517108960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101757

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: 2023-11-16
• Device Publish Date: 2023-11-08

On-Brand Devices [P10x/8-4 MHz]

• 00841517105044: Diagnostic Ultrasound Transducer
• 00841517104894: Diagnostic Ultrasound Transducer
• 00841517102920: Diagnostic Ultrasound Transducer
• 00841517100490: Diagnostic Ultrasound Transducer
• 00841517100483: Diagnostic Ultrasound Transducer
• 00841517106911: Diagnostic Ultrasound Transducer
• 00841517107505: Diagnostic Ultrasound Transducer
• 00841517108960: Diagnostic Ultrasound Transducer
• 00841517110529: Diagnostic Ultrasound Transducer