HITACHI HEALTHCARE AMERICAS

GUDID 00869047000448

Ultrasound transducer

HITACHI HEALTHCARE AMERICAS CORPORATION

Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer

• Primary Device ID: 00869047000448
• NIH Device Record Key: 901a0333-0aa1-4fdc-aeaa-4cacfe9f9e44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HITACHI HEALTHCARE AMERICAS
• Version Model Number: C9150LA
• Company DUNS: 603156043
• Company Name: HITACHI HEALTHCARE AMERICAS CORPORATION
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869047000448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K134016

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

[00869047000448]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-07
• Device Publish Date: 2020-06-29

On-Brand Devices [HITACHI HEALTHCARE AMERICAS]

• 00869047000424: Ultrasound Transducer
• 00869047000417: Ultrasound transducer
• 00869047000400: Ultrasound Transducer
• 00869047000448: Ultrasound transducer