LINEAR ARRAY PROBE

GUDID 04987670000522

LINEAR ARRAY PROBE

CANON MEDICAL SYSTEMS CORPORATION

Surgical ultrasound imaging transducer
Primary Device ID04987670000522
NIH Device Record Keyb894e889-6b11-40c9-90e2-2781183f12a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameLINEAR ARRAY PROBE
Version Model NumberPEF-704LA
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
GS104987670000522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04987670000522]

Ethylene Oxide


Device Entry Metadata

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

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

04987670104541 - DIAGNOSTIC ULTRASOUND SYSTEM2024-07-15
04987670104558 - DIAGNOSTIC ULTRASOUND SYSTEM2024-07-15
04987670106095 - Aquilion Serve SP2024-07-12
04987670100925 - BIOPSY ADAPTOR2024-04-22
04987670104626 - LINEAR ARRAY TRANSDUCER2024-04-22
04987670104633 - LINEAR ARRAY TRANSDUCER2024-04-22
04987670104640 - ENDOCAVITARY TRANSDUCER2024-04-22
04987670104664 - CONVEX ARRAY TRANSDUCER2024-04-22

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