EZU-PA5C4

GUDID 04573596210918

Probe

FUJIFILM HEALTHCARE CORPORATION

Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking holder, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable Ultrasound imaging system tracking positioner, reusable
Primary Device ID04573596210918
NIH Device Record Key07d1b359-9839-477c-9008-b703f4318962
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZU-PA5C4
Version Model NumberEZU-PA5C4
Company DUNS718262719
Company NameFUJIFILM HEALTHCARE CORPORATION
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
GS104573596210918 [Primary]
GS104580292773647 [Previous]

FDA Product Code

OIJBiopsy Needle Guide Kit

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


[04573596210918]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-26
Device Publish Date2021-07-18

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04573596214336 - C4212024-01-30 Probe
04573596214503 - CC41R22024-01-30 Probe
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