Ingenia 1.5T

GUDID 00884838055322

Magnetic Resonance Equipment

Philips Medical Systems Nederland B.V.

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Primary Device ID00884838055322
NIH Device Record Key8e7b00be-522f-46f0-9bb1-a808c794e023
Commercial Distribution StatusIn Commercial Distribution
Brand NameIngenia 1.5T
Version Model Number781341
Company DUNS413819707
Company NamePhilips Medical Systems Nederland B.V.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100884838055322 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNISystem, nuclear magnetic resonance spectroscopic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-04
Device Publish Date2016-09-23

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