EZU-PA532

GUDID 04573596210826

Needle Guide Bracket

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 ID04573596210826
NIH Device Record Key3a368f3e-afd1-4c8a-b810-d1b74bd9980c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZU-PA532
Version Model NumberEZU-PA532
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
GS104573596210826 [Primary]
GS104580292774187 [Previous]

FDA Product Code

OIJBiopsy Needle Guide Kit

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

Ethylene Oxide


[04573596210826]

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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