FDA.report

Barco

Primary DI
05415334053717
Company
Barco NV
Model
MDRC-2422
Catalog number
K9356038A1X
Device description
MDRC-2422 SNEW
Published
2025-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
371618773
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
05415334053717PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
05415334053717PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
LMDSystem, Digital Image Communications, Radiological1Radiology892.2020NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Image display unit, colourAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
+1 866-302-7939service.medical.usa@barco.com

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05415334050020BarcoMDSC-8532 K93530182025-12-22
05415334050013BarcoMDSC-8532K93530192025-12-01
05415334053045Eonis 3DMDRC-8127K9301153A2X2025-12-01
05415334060159Nio 5.8MP GrayMDNG-6221K9300375C1X2025-12-01
05415334054967Nio 5.8MP ColorMDNC-6121K9300360C1X2025-08-11
05415334054974Nio 5.8MP ColorMDNC-6121K9300361C1X2025-08-11
05415334054981Nio 5.8MP GrayMDNG-6221K9300370C1X2025-08-11
05415334054998Nio 5.8MP GrayMDNG-6221K9300372C1X2025-08-11
05415334058415BarcoIWT 2.4.xK93082542025-08-05
05415334051133SterisVividImage 32 4K MiniLEDRLM324KMINI2025-06-05
05415334053458BarcoMNA-4406003014792025-06-04
05415334053472BarcoMNA-1206003014812025-06-04
05415334053663BarcoMNA-2406003014822025-06-04
05415334053670BarcoMNA-4206003060272025-06-04
05415334049895Coronis Fusion 4MPMDCC-4430K9301626B2X2025-04-16
05415334049901Coronis Fusion 4MPMDCC-4430K9301628B2X2025-04-16
05415334049925Coronis Fusion 6MPMDCC-6530K9301636B2X2025-04-16
05415334049932Coronis Fusion 6MPMDCC-6530K9301638B2X2025-04-16
05415334053724BarcoMDRC-2422K9356039A1X2025-04-14
05415334053731BarcoMDRC-2422 K9356040A1X2025-04-14

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