FDA.reportPublic FDA data

Gynex

Primary DI
GYNXMI60000
Brand
Gynex
Company
GYNEX CORPORATION
Model
MI-6000
Published
2023-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IBJLight, Microscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IBJLight, MicroscopePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
GYNXMI60000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Basic light microscopeA magnification instrument designed with a standard microscope configuration [the object viewed through an ocular(s) from above] used to magnify and study specimens and small objects by transmitted visible light. It is widely used in laboratories and for research and in healthcare facilities where there is a need for such magnification. The device consists of a stand that supports the main components, an ocular body in which the eyepieces are mounted, a nosepiece to support the objectives, a specimen stage, a condenser to focus the light on the specimen, and a source of light [e.g., tungsten (W), halogen] and light port.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012997685
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
GYNX32500Gynex32502023-12-13
GYNX32550Gynex32552023-12-13
GYNX80091Gynex80092023-12-19
GYNX80241Gynex80242023-12-19
GYNX80721Gynex80722023-12-19
GYNX81001Gynex81002023-12-19
GYNX81031Gynex81032023-12-19
GYNX82001Gynex82002023-12-19
GYNX292001Gynex29-2002023-12-26
GYNX293001Gynex29-3002023-12-26
GYNX298501Gynex29-8502023-12-26
GYNX31301Gynex31302023-12-26
GYNX31351Gynex31352023-12-26
GYNX32071Gynex32052023-12-26
GYNX16000Gynex16002023-12-26
GYNX291000Gynex29-1002023-12-26
GYNX292000Gynex29-3002023-12-26
GYNX293500Gynex29-3502023-12-26
GYNX295500Gynex29-5502023-12-26
GYNX297000Gynex29-7002023-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00664816005866LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005873LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005934LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005941LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005958LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005965LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
08052691050002NED-DP Nano Eye Device for Digital PathologyNTP NANO TECH PROJECTS SRLIBJ2024-11-11
08052691050019NED-DH Nano Eye Device for Digital HematologyNTP NANO TECH PROJECTS SRLIBJ2024-11-11
04260158450065FotoFinder medicamFotoFinder Systems GmbHIBJ2023-08-07
04260158450089FotoFinder leviacamFotoFinder Systems GmbHIBJ2023-08-07
00664816002391LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002407LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002414LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002421LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002759LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00852728008864SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00860009669192SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00860010027707SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00850147000094MoleScope LiteMetaOptima Technology IncIBJ2023-02-17
85014700009486MoleScope LiteMetaOptima Technology IncIBJ2023-02-17
00304040043400Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043417Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043424Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043431Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043448Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00664816000908LW Scientific, IncLW SCIENTIFIC, INC.IBJ2021-04-09
00664816000922LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000939LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000946LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000953LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09