NIRO-200NX

GUDID 04582389010062

HAMAMATSU PHOTONICS K.K.

Tissue saturation oximeter
Primary Device ID04582389010062
NIH Device Record Key67458c7a-452f-4a32-b2aa-314c029380cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIRO-200NX
Version Model NumberC10448-20
Company DUNS704524537
Company NameHAMAMATSU PHOTONICS K.K.
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
GS104582389010062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUDOximeter, Tissue Saturation

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 Date2016-09-23

Devices Manufactured by HAMAMATSU PHOTONICS K.K.

04582389010871 - PDE-GEN32023-06-09
04582389010659 - NanoZoomer S360MD Slide scanner system2022-10-10
04582389010031 - PDE2018-07-06
04582389010062 - NIRO-200NX2018-07-06
04582389010062 - NIRO-200NX2018-07-06
04582389010093 - pde-neo2018-07-06
04582389010543 - pde-neoII2018-07-06

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