DEFINA

GUDID 04961333249176

PENTAX Medical Video Processor EPK-3000

HOYA CORPORATION

Endoscopic video image processing unit
Primary Device ID04961333249176
NIH Device Record Keyee035f2d-ae3e-4de1-9740-f6d3e8a8af21
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEFINA
Version Model NumberEPK-3000
Company DUNS691519705
Company NameHOYA 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
GS104961333249176 [Direct Marking]
GS104961333249183 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEAEndoscope, accessories, image post-processing for color enhancement

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-08
Device Publish Date2023-10-31

On-Brand Devices [DEFINA]

04961333244874Made in Thailand
04961333249176PENTAX Medical Video Processor EPK-3000

Trademark Results [DEFINA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DEFINA
DEFINA
97052005 not registered Live/Pending
Vitagoods, LLC
2021-09-29
DEFINA
DEFINA
79301464 not registered Live/Pending
Crespel & Deiters GmbH & Co. KG
2020-11-24
DEFINA
DEFINA
79166978 4911425 Live/Registered
HOYA CORPORATION
2014-12-26

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