Transducer S12BP4

GUDID 00860007188343

Transducer S12BP4 – 11 mm Neurosurgery Probe

Fujifilm Healthcare Americas Corporation

Surgical ultrasound imaging transducer
Primary Device ID00860007188343
NIH Device Record Key39199406-95e7-438b-9888-1a4d62e18e56
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransducer S12BP4
Version Model NumberS12BP4
Company DUNS603156043
Company NameFujifilm Healthcare Americas Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860007188343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00860007188343]

Hydrogen Peroxide


[00860007188343]

Hydrogen Peroxide


[00860007188343]

Hydrogen Peroxide


[00860007188343]

Hydrogen Peroxide


[00860007188343]

Hydrogen Peroxide


[00860007188343]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-16
Device Publish Date2022-06-08

Devices Manufactured by Fujifilm Healthcare Americas Corporation

00854904006039 - Synapse Pathology2023-06-26 Dynamyx Digital Pathology Software is a client-server software device used for importing, displaying, navigating, and annotating
00860007188343 - Transducer S12BP42022-06-16Transducer S12BP4 – 11 mm Neurosurgery Probe
00860007188343 - Transducer S12BP42022-06-16 Transducer S12BP4 – 11 mm Neurosurgery Probe

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