Eonis 3D K9301153A2X

GUDID 05415334053045

MDRC-8127 SLIB

Barco NV

Image display unit, colour
Primary Device ID05415334053045
NIH Device Record Key13b437c0-4983-4b9a-bc14-9ea9c76bbc31
Commercial Distribution StatusIn Commercial Distribution
Brand NameEonis 3D
Version Model NumberMDRC-8127
Catalog NumberK9301153A2X
Company DUNS371618773
Company NameBarco NV
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Phone+1 866-302-7939
Emailservice.medical.usa@barco.com
Phone+1 866-302-7939
Emailservice.medical.usa@barco.com
Phone+1 866-302-7939
Emailservice.medical.usa@barco.com
Phone+1 866-302-7939
Emailservice.medical.usa@barco.com
Phone+1 866-302-7939
Emailservice.medical.usa@barco.com
Phone+1 866-302-7939
Emailservice.medical.usa@barco.com
Phone+1 866-302-7939
Emailservice.medical.usa@barco.com
Phone+1 866-302-7939
Emailservice.medical.usa@barco.com
Phone+1 866-302-7939
Emailservice.medical.usa@barco.com
Phone+1 866-302-7939
Emailservice.medical.usa@barco.com
Phone+1 866-302-7939
Emailservice.medical.usa@barco.com
Phone+1 866-302-7939
Emailservice.medical.usa@barco.com
Phone+1 866-302-7939
Emailservice.medical.usa@barco.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105415334053045 [Primary]

FDA Product Code

LMDSystem, Digital Image Communications, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-09
Device Publish Date2025-12-01

Devices Manufactured by Barco NV

05415334050013 - Barco2025-12-09 MDSC-8532 NXF M2
05415334053045 - Eonis 3D2025-12-09MDRC-8127 SLIB
05415334053045 - Eonis 3D2025-12-09 MDRC-8127 SLIB
05415334060159 - Nio 5.8MP Gray2025-12-09 MDNG-6221 SPEF
05415334054967 - Nio 5.8MP Color2025-08-19 MDNC-6121 SPEF
05415334054974 - Nio 5.8MP Color2025-08-19 MDNC-6121 SNEF
05415334054981 - Nio 5.8MP Gray2025-08-19 MDNG-6221 SPEF
05415334054998 - Nio 5.8MP Gray2025-08-19 MDNG-6221 SNEF
05415334058415 - Barco2025-08-13 Medical image management and processing SW

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