ENDOVAGINAL TRANSDUCER

GUDID 04987670001635

ENDOVAGINAL TRANSDUCER

CANON MEDICAL SYSTEMS CORPORATION

Rectal/vaginal ultrasound imaging transducer
Primary Device ID04987670001635
NIH Device Record Key398ae788-f2f2-47fc-aa36-06f8cd281676
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOVAGINAL TRANSDUCER
Version Model NumberPVM-621VT
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
GS104987670001635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04987670001635]

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

On-Brand Devices [ENDOVAGINAL TRANSDUCER]

04987670001642ENDOVAGINAL TRANSDUCER
04987670001635ENDOVAGINAL TRANSDUCER

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