FDA.reportPublic FDA data

INAMI

Primary DI
04547451328650
Brand
INAMI
Company
INAMI & CO., LTD.
Model
KDM-3
Device description
KDM-3 M-CHARTS
Published
2023-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HOQGrid, Amsler

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOQGrid, AmslerOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547451328650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547451328650045474513286504547451328650

GMDN Terms#

Term, Definition table
TermDefinition
Amsler gridAn ophthalmic device that is a series of charts with grids of different sizes that are held at 30 centimeters distance from the patient and intended to rapidly detect central and paracentral irregularities in the visual field.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690688742
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547451339212INAMI25R-0000822026-01-29
04547451338338INAMIKDM-42025-12-19
04547451339045Inami25R-0000692025-12-05
04547451338062Inami Ophthalmic InstrumentsM-2225S2024-10-07
00454745102558INAMIL-05442025-11-12
04547451081777INAMIL-05412025-11-12
04547451338321INAMIL-03002025-08-29
04547451043744Inami Ophthalmic InstrumentsS-3252025-08-06
04547451338628Inami Ophthalmic InstrumentsM-2221S2025-06-19
04547451338635Inami Ophthalmic InstrumentsM-2221L2025-06-19
04547451338642Inami Ophthalmic InstrumentsM-2221R2025-06-19
04547451336808Inami Ophthalmic InstrumentsM-22252025-06-13
04547451333883Inami Ophthalmic InstrumentsK-0391T2025-05-28
04547451336815Inami Ophthalmic InstrumentsDS-0162025-04-09
04547451337560Inami Ophthalmic InstrumentsDS-0162025-04-09
04547451026273INAMIL-2510B2025-03-06
04547451026280INAMIL-2510HB2025-03-06
04547451336792Inami Ophthalmic InstrumentsS-892024-10-08
04547451337904Inami Ophthalmic InstrumentsS-942024-10-08
04547451337690Inami Ophthalmic InstrumentM-22702024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547451338338INAMIINAMI & CO., LTD.HOQ2025-12-19
EOMA32120AlleyeOCULOCARE medical AGHOQ2023-05-15
00860004152705Home Vision Monitor®VITAL ART AND SCIENCE, LLCHOQ2020-08-17