Transducer eL18-4

GUDID 00884838070813

Philips Ultrasound, Inc.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00884838070813
NIH Device Record Keybe3e6f8d-f761-41c9-81f3-d354db6f958c
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransducer eL18-4
Version Model Number989605456291
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 Batchfalse
Serial Numbertrue
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
GS100884838070813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-02

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