PHASED ARRAY TRANSDUCER

GUDID 04987670001161

PHASED ARRAY TRANSDUCER

CANON MEDICAL SYSTEMS CORPORATION

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID04987670001161
NIH Device Record Key0da14956-cde4-45e6-87a9-e49dd8d22b55
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHASED ARRAY TRANSDUCER
Version Model NumberPSM-70AT
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
GS104987670001161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04987670001161]

Ethylene Oxide;Hydrogen Peroxide


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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04987670004377PHASED ARRAY TRANSDUCER
04987670003356PHASED ARRAY TRANSDUCER
04987670003349PHASED ARRAY TRANSDUCER
04987670003332PHASED ARRAY TRANSDUCER
04987670002953PHASED ARRAY TRANSDUCER
04987670002946PHASED ARRAY TRANSDUCER
04987670002823PHASED ARRAY TRANSDUCER
04987670002816PHASED ARRAY TRANSDUCER
04987670001291PHASED ARRAY TRANSDUCER
04987670001284PHASED ARRAY TRANSDUCER
04987670001277PHASED ARRAY TRANSDUCER
04987670001260PHASED ARRAY TRANSDUCER
04987670001253PHASED ARRAY TRANSDUCER
04987670001246PHASED ARRAY TRANSDUCER
04987670001239PHASED ARRAY TRANSDUCER
04987670001161PHASED ARRAY TRANSDUCER
04987670001154PHASED ARRAY TRANSDUCER
04987670001147PHASED ARRAY TRANSDUCER
04987670001130PHASED ARRAY TRANSDUCER
04987670001123PHASED ARRAY TRANSDUCER
04987670001116PHASED ARRAY TRANSDUCER
04987670001109PHASED ARRAY TRANSDUCER
04987670104862PSI-28VX

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