s5 PC Module

GUDID 00845225012304

VOLCANO CORPORATION

Cardiovascular ultrasound imaging system
Primary Device ID00845225012304
NIH Device Record Keyb63523f4-7328-49bf-8d98-346b26498426
Commercial Distribution StatusIn Commercial Distribution
Brand Names5 PC Module
Version Model Number807301042
Company DUNS135179237
Company NameVOLCANO 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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100845225012304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBJCatheter, Ultrasound, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

On-Brand Devices [s5 PC Module]

00184360000525807301001
00845225012304807301042

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