PCR Eleva 732066

GUDID 00884838074569

System Image Processing, Radiological

Philips Medical Systems DMC GmbH

Computed radiography digital imaging scanner
Primary Device ID00884838074569
NIH Device Record Key02272fcc-3338-4c8d-a8e7-57414a08659e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePCR Eleva
Version Model Number9890-010-83831
Catalog Number732066
Company DUNS314101218
Company NamePhilips Medical Systems DMC GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
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
GS100884838074569 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2016-09-19

On-Brand Devices [PCR Eleva]

00884838074569System Image Processing, Radiological
00884838004047System Image Processing, Radiological

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