PREIRUS

GUDID 04961333243136

HV-PREIRUS SYSTEM WITHOUT ELASTOGTAPHY

PENTAX OF AMERICA, INC.

General-purpose ultrasound imaging system
Primary Device ID04961333243136
NIH Device Record Key39e3ced6-7001-4c3f-a3fc-6c9ad1f8ed25
Commercial Distribution StatusIn Commercial Distribution
Brand NamePREIRUS
Version Model NumberHV-PREIRUS-B
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
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 Datefalse
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
GS104961333243136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-03-12

On-Brand Devices [PREIRUS]

04961333243143ULTRASOUND SYSTEM WITH SONO - DEMO
04961333243136HV-PREIRUS SYSTEM WITHOUT ELASTOGTAPHY
04961333243129HV-PREIRUS DEMO ESCORT CASE
04961333243112ADVANCED DIGITAL ULTRASOUND SYSTEM
04961333243105HITACHI 5.1 SOFTWARE UPGRADE PREIRUS
04961333240357ADVANCED DIGITAL ULTRASOUND SYSTEM (USED)

Trademark Results [PREIRUS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PREIRUS
PREIRUS
77737815 3715222 Live/Registered
KABUSHIKI KAISHA HITACHI SEISAKUSHO
2009-05-15

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