PDE-GEN3

GUDID 04582389010871

HAMAMATSU PHOTONICS K.K.

Surgical microscope fluorescent angiography system
Primary Device ID04582389010871
NIH Device Record Key07ba8815-3ef8-4a5e-ae29-daf6ae47c9cb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePDE-GEN3
Version Model NumberC13999-40
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104582389010871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZISystem, X-Ray, Angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-09
Device Publish Date2023-06-01

Devices Manufactured by HAMAMATSU PHOTONICS K.K.

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

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