ICT/8-5 MHZ P04538

GUDID 00841517101268

FUJIFILM SONOSITE, INC.

Rectal/vaginal ultrasound imaging transducer

• Primary Device ID: 00841517101268
• NIH Device Record Key: f8c2da6a-3c2f-4452-8c0d-7abe9c8e39ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ICT/8-5 MHZ
• Version Model Number: P04538-17
• Catalog Number: P04538
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517101268 [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: 2016-09-21

On-Brand Devices [ICT/8-5 MHZ]

• 00841517101275: P04538-17A
• 00841517101268: P04538-17