C421

GUDID 04573596214336

Probe

FUJIFILM HEALTHCARE CORPORATION

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID04573596214336
NIH Device Record Keye114d8c9-59ac-4a02-b58d-42add4f1ac5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameC421
Version Model NumberC421
Company DUNS680160734
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
GS104573596214336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


[04573596214336]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-30
Device Publish Date2024-01-22

Devices Manufactured by FUJIFILM HEALTHCARE CORPORATION

04573596204382 - FUJIFILM2024-07-22
04573596212011 - L31KP2024-02-02 Probe
04573596212318 - S3ESCLS2024-02-02 Probe
04573596212035 - L352024-01-30 Probe
04573596212455 - UST-2266-52024-01-30 Probe
04573596214176 - CL4416R12024-01-30 Probe
04573596214336 - C4212024-01-30Probe
04573596214336 - C4212024-01-30 Probe
04573596214503 - CC41R22024-01-30 Probe

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