EOS®

GUDID 03663999000009

EOS IMAGING

Stationary basic diagnostic x-ray system, digital
Primary Device ID03663999000009
NIH Device Record Key878c75db-402a-4ad2-a7ce-46d5b57352c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameEOS®
Version Model Number3.3
Company DUNS762320968
Company NameEOS IMAGING
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8669335301
Emailcontact@eos-imaging.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS103663999000009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPRSystem, X-Ray, Stationary

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-28
Device Publish Date2016-09-21

On-Brand Devices [EOS®]

036639990000163.4
036639990000093.3

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