MC12-3 Ultrasound Transducer

GUDID 00884838093935

Philips Ultrasound, Inc.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00884838093935
NIH Device Record Key9913d0d5-579d-4db2-8242-261ec9b1a52a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMC12-3 Ultrasound Transducer
Version Model Number989605495721
Company DUNS063377717
Company NamePhilips Ultrasound, Inc.
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100884838093935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, imaging, pulsed doppler, ultrasonic


Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-19
Device Publish Date2020-03-11

Devices Manufactured by Philips Ultrasound, Inc.

00884838093935 - MC12-3 Ultrasound Transducer2020-03-19
00884838093935 - MC12-3 Ultrasound Transducer2020-03-19
00884838099111 - EPIQ ELITE Ultrasound Systtem2020-03-18
00884838091672 - QLAB Advanced Quantification Software2020-03-16
00884838084322 - QLAB Advanced Quantification Software2020-03-16
00884838090736 - QLAB Advanced Quantification Software2020-03-16
00884838023987 - Transducer X7-2t2019-09-30
00884838024304 - Transducer C9-3v2019-09-30
00884838024649 - Transducer PA4-22019-09-30

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