XPERIUS Ultrasound System

GUDID 00884838083165

Philips Ultrasound, Inc.

General-purpose ultrasound imaging system
Primary Device ID00884838083165
NIH Device Record Key62485907-34c8-463f-b0e4-44a969f16c71
Commercial Distribution StatusIn Commercial Distribution
Brand NameXPERIUS Ultrasound System
Version Model Number989605452211
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
GS100884838083165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-14
Device Publish Date2017-03-17

On-Brand Devices [XPERIUS Ultrasound System]

00884838085060989605467901
00884838083165989605452211
00884838097698795101

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.