LINEAR ARRAY TRANSDUCER

GUDID 04987670000997

LINEAR ARRAY TRANSDUCER

CANON MEDICAL SYSTEMS CORPORATION

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID04987670000997
NIH Device Record Keydb2a5de3-f9cb-42f7-9c91-6ff4ffafcecb
Commercial Distribution StatusIn Commercial Distribution
Brand NameLINEAR ARRAY TRANSDUCER
Version Model NumberPLT-805AT
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
GS104987670000997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04987670000997]

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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04987670004087LINEAR ARRAY TRANSDUCER
04987670003523LINEAR ARRAY TRANSDUCER
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04987670003400LINEAR ARRAY TRANSDUCER
04987670003394LINEAR ARRAY TRANSDUCER
04987670003219LINEAR ARRAY TRANSDUCER
04987670002977LINEAR ARRAY TRANSDUCER
04987670002854LINEAR ARRAY TRANSDUCER
04987670002847LINEAR ARRAY TRANSDUCER
04987670000997LINEAR ARRAY TRANSDUCER
04987670000980LINEAR ARRAY TRANSDUCER
04987670000973LINEAR ARRAY TRANSDUCER
04987670000966LINEAR ARRAY TRANSDUCER
04987670000959LINEAR ARRAY TRANSDUCER
04987670000942LINEAR ARRAY TRANSDUCER
04987670000928LINEAR ARRAY TRANSDUCER
04987670000911LINEAR ARRAY TRANSDUCER
04987670000904LINEAR ARRAY TRANSDUCER
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04987670000812LINEAR ARRAY TRANSDUCER
04987670000805LINEAR ARRAY TRANSDUCER
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04987670000782LINEAR ARRAY TRANSDUCER
04987670000775LINEAR ARRAY TRANSDUCER
04987670000720LINEAR ARRAY TRANSDUCER
04987670104176PLI-605BX
04987670103568PLI-3003BX
04987670103100PLI-2002BT
04987670103094PLT-1202BT
04987670103070PLI-705BX
04987670100956UAGV-028A
04987670104633PLC-1004LT
04987670104626PLC-704LT
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