HITACHI, LTD.

GUDID 04562122958820

Probe

HITACHI, LTD.

Surgical ultrasound imaging transducer

• Primary Device ID: 04562122958820
• NIH Device Record Key: 982de80e-607c-400f-aebf-296ab3d13de5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HITACHI, LTD.
• Version Model Number: L51K
• Company DUNS: 693002605
• Company Name: HITACHI, LTD.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04562122958820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163505

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

[04562122958820]

Ethylene Oxide;Peracetic Acid;Liquid Chemical;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-08

On-Brand Devices [ HITACHI, LTD. ]

• 04562122958936: Probe
• 04562122958820: Probe