C8x/8-5 MHz P08010

GUDID 00841517102968

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517102968
• NIH Device Record Key: d60e0659-3dd8-432e-875c-b57bf5d0ac03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C8x/8-5 MHz
• Version Model Number: P08010-71A
• Catalog Number: P08010
• 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

Customer Support Contacts

• Phone: +1(999)999-9999
• Email: xyz@xyz.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517102968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053069

FDA Product Code

• ITX: Transducer, ultrasonic, diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-24

On-Brand Devices [C8x/8-5 MHz]

• 00841517104795: Diagnostic Ultrasound Transducer
• 00841517102968: Diagnostic Ultrasound Transducer
• 00841517102586: Diagnostic Ultrasound Transducer
• 00841517106973: Diagnostic Ultrasound Transducer