LINEAR ARRAY TRANSDUCER

GUDID 04987670000911

LINEAR ARRAY TRANSDUCER

CANON MEDICAL SYSTEMS CORPORATION

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID04987670000911
NIH Device Record Keyc6ac6159-b950-458d-8f36-13f049a23e87
Commercial Distribution StatusIn Commercial Distribution
Brand NameLINEAR ARRAY TRANSDUCER
Version Model NumberPLT-1204AX
Company DUNS690575113
Company NameCANON MEDICAL SYSTEMS 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-8004211968
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS104987670000911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04987670000911]

Hydrogen Peroxide;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-01

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04987670000997LINEAR ARRAY TRANSDUCER
04987670000980LINEAR ARRAY TRANSDUCER
04987670000973LINEAR ARRAY TRANSDUCER
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04987670000928LINEAR ARRAY TRANSDUCER
04987670000911LINEAR ARRAY TRANSDUCER
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04987670000782LINEAR ARRAY TRANSDUCER
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04987670104176PLI-605BX

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