ENDOCAVITARY TRANSDUCER

GUDID 04987670001604

ENDOCAVITARY TRANSDUCER

CANON MEDICAL SYSTEMS CORPORATION

Rectal ultrasound imaging system transducer
Primary Device ID04987670001604
NIH Device Record Key81d2bdea-a33b-4d6c-9612-1c2c56e6e02b
Commercial Distribution StatusIn Commercial Distribution
Brand NameENDOCAVITARY TRANSDUCER
Version Model NumberPVL-715RT
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
GS104987670001604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04987670001604]

Hydrogen Peroxide;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

On-Brand Devices [ENDOCAVITARY TRANSDUCER]

04987670004391ENDOCAVITARY TRANSDUCER
04987670004308ENDOCAVITARY TRANSDUCER
04987670004292ENDOCAVITARY TRANSDUCER
04987670004285ENDOCAVITARY TRANSDUCER
04987670004216ENDOCAVITARY TRANSDUCER
04987670004209ENDOCAVITARY TRANSDUCER
04987670003424ENDOCAVITARY TRANSDUCER
04987670003387ENDOCAVITARY TRANSDUCER
04987670003196ENDOCAVITARY TRANSDUCER
04987670002809ENDOCAVITARY TRANSDUCER
04987670001901ENDOCAVITARY TRANSDUCER
04987670001888ENDOCAVITARY TRANSDUCER
04987670001864ENDOCAVITARY TRANSDUCER
04987670001765ENDOCAVITARY TRANSDUCER
04987670001673ENDOCAVITARY TRANSDUCER
04987670001604ENDOCAVITARY TRANSDUCER
04987670104640PVC-781VLT

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