LINEAR ARRAY BIOPSY PROBE

GUDID 04987670000645

LINEAR ARRAY BIOPSY PROBE

CANON MEDICAL SYSTEMS CORPORATION

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID04987670000645
NIH Device Record Key9b3d903c-6fbf-4803-9a82-c3a545da4b6f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLINEAR ARRAY BIOPSY PROBE
Version Model NumberPLF-308P
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
GS104987670000645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04987670000645]

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

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

04987670100680 - BIOPSY ADAPTOR2024-04-16
04987670100697 - BIOPSY ADAPTOR2024-04-16
04987670100802 - BIOPSY ADAPTOR2024-04-16
04987670100819 - BIOPSY ADAPTOR2024-04-16
04987670100895 - BIOPSY ADAPTOR2024-04-16
04987670100918 - BIOPSY ADAPTOR2024-04-16
04987670100949 - BIOPSY ADAPTOR2024-04-16
04987670100956 - LINEAR ARRAY TRANSDUCER2024-04-16

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