DEFINA

GUDID 04961333245208

DEFINA HD VIDEO PROCESSOR (US USED)

PENTAX OF AMERICA, INC.

Endoscopic video image processing unit
Primary Device ID04961333245208
NIH Device Record Key0095b7e8-b2d8-4971-a77c-c7813c2eab73
Commercial Distribution StatusIn Commercial Distribution
Brand NameDEFINA
Version Model NumberEPK-3000-US
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
GS104961333245208 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-21
Device Publish Date2018-04-16

On-Brand Devices [DEFINA]

04961333245208DEFINA HD VIDEO PROCESSOR (US USED)
04961333225262DEFINA HD VIDEO PROCESSOR (US NEW)

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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