HITACHI HEALTHCARE AMERICAS

GUDID 00869047000448

Ultrasound transducer

HITACHI HEALTHCARE AMERICAS CORPORATION

Surgical ultrasound imaging transducer
Primary Device ID00869047000448
NIH Device Record Key901a0333-0aa1-4fdc-aeaa-4cacfe9f9e44
Commercial Distribution StatusIn Commercial Distribution
Brand NameHITACHI HEALTHCARE AMERICAS
Version Model NumberC9150LA
Company DUNS603156043
Company NameHITACHI 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100869047000448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-07
Device Publish Date2020-06-29

On-Brand Devices [HITACHI HEALTHCARE AMERICAS]

00869047000424Ultrasound Transducer
00869047000417Ultrasound transducer
00869047000400Ultrasound Transducer
00869047000448Ultrasound transducer

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