FDA.report

Barco

Primary DI
05415334033115
Brand
Barco
Company
Barco NV
Model
MDSC-8527 SSTP
Catalog number
K9352370
Device description
Surgical color monitor
Published
2022-01-24
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

Contact Domains

Product Codes

CodeName
KQMCamera, Surgical And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05415334033115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05415334033115054153340331155415334033115

GMDN Terms

TermDefinition
Image display monitor, colourA mains electricity (AC-powered) visual display unit (VDU), commonly known as a screen or a monitor, used for displaying graphical information under program control in colour, e.g., measured values or images from other devices. Colour is necessary when separating the information of multiple parameters making it easier for the user to read the values. A keyboard may be connected to the unit for interactive manipulation of the data by an operator. This GMDN code is the product identifier for the monitor only, which will not include the device(s) from which the data is generated and includes different screen technologies, e.g., cathode-ray tube (CRT) or liquid crystal display (LCD).

Sterilization Methods

Method

Contacts

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

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
05415334053717BarcoMDRC-2422K9356038A1X2025-04-14
05415334053724BarcoMDRC-2422K9356039A1X2025-04-14

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