ICTx/8-5 MHz

GUDID 00841517100803

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Rectal/vaginal ultrasound imaging transducer

• Primary Device ID: 00841517100803
• NIH Device Record Key: bc3bc38e-9a3b-40fd-a72b-0175fe5528fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICTx/8-5 MHz
• Version Model Number: P11881-10A
• 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: 1-877-657-8118
• Email: ffss-service@fujifilm.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517100803 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102390

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: 2016-09-14

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

• 00841517105051: Diagnostic Ultrasound Transducer
• 00841517104849: Diagnostic Ultrasound Transducer
• 00841517103750: Diagnostic Ultrasound Transducer
• 00841517103743: Diagnostic Ultrasound Transducer
• 00841517102890: Diagnostic Ultrasound Transducer
• 00841517100803: Diagnostic Ultrasound Transducer
• 00841517100797: Diagnostic Ultrasound Transducer
• 00841517100421: Diagnostic Ultrasound Transducer
• 00841517100414: Diagnostic Ultrasound Transducer
• 00841517106287: Diagnostic Ultrasound Transducer
• 00841517106232: Diagnostic Ultrasound Transducer
• 00841517106935: Diagnostic Ultrasound Transducer
• 00841517107390: Diagnostic Ultrasound Transducer
• 00841517108939: diagnostic Ultrasound transducer