FDA.reportPublic FDA data

Barco

Primary DI
05415334033665
Brand
Barco
Company
Barco NV
Model
MDPC-8127
Catalog number
K9301101A
Device description
MDPC-8127
Published
2021-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PZZDigital pathology display

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZZDigital Pathology DisplayPathology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203364000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203364000MDPC-8127Barco N.V.2021-04-15PSY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415334033665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415334033665054153340336655415334033665

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)302-7939service.medical.usa@barco.com

Regulatory Flags#

DUNS number
371618773
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415334058460BarcoNMS 22026-11-03
05415334059122BarcoMNA-420 ENC ANAK93033402026-11-03
05415334062573BarcoMNA-420 ENC ANAK9303340B2026-11-03
05415334062993BarcoMNA-420 ENC ANAK9303340X2026-11-03
05415334059405BarcoMNA-410 WPMK93516812026-10-12
05415334050037BarcoMDSC-8532K93530172026-10-01
05415334050068BarcoMDSC-8532K93530152026-10-01
05415334059139BarcoMCC-300K93513022026-09-21
05415334059924BarcoMCC-300K93513012026-09-21
05415334059931BarcoMCC-300K93513002026-09-21
05415334001671BarcoMDSC-8255K9307933022020-07-29
05415334001879BarcoMDSC-8255K9307930022020-07-29
05415334001886BarcoMDRC-2222K93079432020-07-29
05415334001961BarcoMDSC-8255K93079322020-07-29
05415334001978BarcoMDSC-2324K93079482020-07-29
05415334002098BarcoMDSC-2326K93079512020-07-29
05415334002104BarcoMDSC-2326K93079522020-07-29
05415334002227BarcoMDSC-2326K93079542020-07-29
05415334002913BarcoMDSC-2326K9307951B2020-07-29
05415334002920BarcoMDSC-2326K9307954B2020-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970027820902BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
06970027820940BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
06970027821077BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
06970027821084BeaconShenzhen Beacon Display Technology Co., Ltd.PZZ2025-03-18
05051663010467EprediaSHANDON DIAGNOSTICS LIMITEDPZZ2025-03-10
05415334033603BarcoBarco NVPZZ2021-07-05
05415334001732BarcoBarco NVPZZ2021-06-28