ENDOPRO STANDALONEC CAPTURE WORKSTATION

GUDID 04961333248025

ENDOPRO CAPTURE WORKSTATION, STANDALONE

PENTAX OF AMERICA, INC.

Medical image management system
Primary Device ID04961333248025
NIH Device Record Key556eecc2-3c05-4279-b5f7-055bccdf397a
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOPRO STANDALONEC CAPTURE WORKSTATION
Version Model NumberKBM68346
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS104961333248025 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-03
Device Publish Date2020-03-26

Devices Manufactured by PENTAX OF AMERICA, INC.

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04961333248117 - Pentax of America2022-11-14 Capture Module
04961333248445 - C2 CryoBalloon Nitroclip2020-08-17 NitroClip
00854924006408 - C2 CryoBalloon EndoGrip2020-08-06 EndoGrip
04961333248001 - ENDOPRO REVIEW WORKSTATION2020-04-03 ENDOPRO REVIEW WORKSTATION
04961333248018 - ENDOPRO NETWORK CAPTURE WORKSTATION2020-04-03 ENDOPRO CAPTURE WORKSTATION, NETWORK
04961333248025 - ENDOPRO STANDALONEC CAPTURE WORKSTATION2020-04-03ENDOPRO CAPTURE WORKSTATION, STANDALONE
04961333248025 - ENDOPRO STANDALONEC CAPTURE WORKSTATION2020-04-03 ENDOPRO CAPTURE WORKSTATION, STANDALONE
04961333244355 - BRANDMAX2020-02-06 BRANDMAX TRI CLEAN ULTRASONIC CLEANER

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