Pentax of America

GUDID 04961333248117

Capture Module

PENTAX OF AMERICA, INC.

Soluble tumour necrosis factor receptor 1 (sTNFR1) IVD, control
Primary Device ID04961333248117
NIH Device Record Keyc39e1010-d1a2-45c4-b545-cf187a081f8a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePentax of America
Version Model Number9380
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 Producttrue
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
GS104961333248117 [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 Date2022-11-14
Device Publish Date2022-11-04

Devices Manufactured by PENTAX OF AMERICA, INC.

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04961333248117 - Pentax of America2022-11-14Capture Module
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

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