Transducer S12BP4

GUDID 00860007188343

Transducer S12BP4 – 11 mm Neurosurgery Probe

Fujifilm 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

• Primary Device ID: 00860007188343
• NIH Device Record Key: 39199406-95e7-438b-9888-1a4d62e18e56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transducer S12BP4
• Version Model Number: S12BP4
• Company DUNS: 603156043
• Company Name: Fujifilm 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860007188343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122537

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

Sterilization

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

[00860007188343]

Hydrogen Peroxide

[00860007188343]

Hydrogen Peroxide

[00860007188343]

Hydrogen Peroxide

[00860007188343]

Hydrogen Peroxide

[00860007188343]

Hydrogen Peroxide

[00860007188343]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-16
• Device Publish Date: 2022-06-08

Devices Manufactured by Fujifilm Healthcare Americas Corporation

• 00854904006039 - Synapse Pathology: 2023-06-26 Dynamyx Digital Pathology Software is a client-server software device used for importing, displaying, navigating, and annotating
• 00860007188343 - Transducer S12BP4: 2022-06-16Transducer S12BP4 – 11 mm Neurosurgery Probe
• 00860007188343 - Transducer S12BP4: 2022-06-16 Transducer S12BP4 – 11 mm Neurosurgery Probe