EZU-PA5C1

GUDID 04573596210888

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 ID04573596210888
NIH Device Record Keydd3e9fa4-d713-4c6f-b0e7-be7839df0493
Commercial Distribution StatusIn Commercial Distribution
Brand NameEZU-PA5C1
Version Model NumberEZU-PA5C1
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
GS104573596210888 [Primary]
GS104580292774194 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIJBiopsy Needle Guide Kit

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

Ethylene Oxide


[04573596210888]

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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04573596212035 - L352024-01-30 Probe
04573596212455 - UST-2266-52024-01-30 Probe
04573596214176 - CL4416R12024-01-30 Probe
04573596214336 - C4212024-01-30 Probe
04573596214503 - CC41R22024-01-30 Probe
04573596214510 - C253A2024-01-30 Probe

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