FDA.reportPublic FDA data

CuratOR

Primary DI
04995047065968
Brand
CuratOR
Company
EIZO CORPORATION
Model
EX3242
Catalog number
EX3242-FDWT
Device description
32-inch 4K monitor
Published
2023-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231066000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231066000CuratOR EX3242-FDEizo Corporation2023-12-18GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04995047065968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04995047065968049950470659684995047065968

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image display unitAn electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-900-8383support@eizo.com

Regulatory Flags#

DUNS number
691033005
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04995047069485RadiCSVer.5.3RadiCS Ver.5.32026-09-04
04995047071655RadiCSVer.5.2RadiCS LE Ver.5.22026-09-04
04995047071662RadiCSVer.5.3RadiCS LE Ver.5.32026-09-04
04995047069300RadiForce®RX670ARX670A-ARBK2026-07-22
04995047069362RadiForce®RX670ARX670A-BK2026-07-22
04995047072676RadiForce®RX370ARX370A-SIBK2026-07-22
04995047072683RadiForce®RX370ARX370A-BK2026-07-22
04995047072843RadiForce®RX370ARX370A-ARBK2026-07-22
04995047072904RadiForce®MX217AMX217A-SIBK2026-07-22
04995047072935RadiForce®MX217AMX217A-BK2026-07-22
04995047072973RadiForce®RX570ARX570A-ARBK-MD2026-07-22
04995047073055RadiForce®RX570ARX570A-BK-MD2026-07-22
04995047073185RadiForce®RX570ARX570A-BK2026-07-22
04995047073208RadiForce®RX570ARX570A-BK-MD2026-07-22
04995047073277RadiForce®RX570ARX570A-ARBK2026-07-22
04995047073338RadiForce®MX243WAMX243WA-SIBK2026-07-22
04995047073376RadiForce®MX243WAMX243WA-GHBK2026-07-22
04995047073444RadiForce®MX243WAMX243WA-BK2026-07-22
04995047073468RadiForce®RX270ARX270A-BK2026-07-22
04995047073475RadiForce®RX270ARX270A-ARBK2026-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18