L25E/13-6 MHz P07634

GUDID 00841517103989

Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultrasound transducer.

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held

• Primary Device ID: 00841517103989
• NIH Device Record Key: 99348443-7ee5-41e1-95b2-f37c3e8c3210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L25E/13-6 MHz
• Version Model Number: P07634-71A
• Catalog Number: P07634
• 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: xx@xx.xx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841517103989 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-11

On-Brand Devices [L25E/13-6 MHz]

• 00841517103989: Diagnostic Ultrasound System Accessory. Sterile needle guidance kit to be used with P11x ultras
• 00841517103552: TRANSDUCER, L25E/13-6 MHZ, ROHS
• 00841517103361: P07634-72
• 00841517103309: TRANSDUCER, L25E/13-6 MHZ, ROHS