FDA.reportPublic FDA data

zumax

Primary DI
06945095540663
Brand
zumax
Company
Zumax Medical Co., LTD
Model
SLT
Catalog number
50LG3534
Published
2026-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJHLoupe, Binocular, Low Power

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJHLoupe, Binocular, Low PowerOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945095540663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095540663069450955406636945095540663

GMDN Terms#

Term, Definition table
TermDefinition
Surgical binoculars, reusableA pair of lenses intended to be mounted onto a surgeon's spectacles to function as small telescope and provide a magnified image of the visual field during patient examination or surgical intervention. Also known as a surgical loupe, it may be mounted onto the spectacle frames and positioned in front of the spectacle lenses or attached directly onto each of the spectacle lenses. It may also be connected to an external light source or a head-worn light for visual field illumination. This is a reusable device.

Regulatory Flags#

DUNS number
421348837
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945095543787zumaxGL6050475-18102026-05-21
06945095543794zumax10-002110-00212026-05-21
06945095543800zumaxOT8G461E30002026-05-21
06945095543855zumaxSR24B418E18122026-05-21
06945095543909zumaxOT8V468-11102026-05-21
06945095543930zumaxSR24B418E11122026-05-21
06945095543954zumaxEL7010701E30002026-05-21
06945095543978zumaxOT8D461-58132026-05-21
06945095544050zumaxGL6030473-18102026-05-21
06945095544067zumax11-1000801100011000-002026-05-21
06945095544074zumaxSR24B418E51122026-05-21
06945095544098zumax10-001710-00172026-05-21
06945095544111zumaxOT8D461-11102026-05-21
06945095544142zumaxOT8C460-00102026-05-21
06945095544159zumaxSR24B418E58122026-05-21
06945095544173zumaxOT8D461E48102026-05-21
06945095544180zumaxOT8K462-18102026-05-21
06945095544210zumaxSR24A418-48122026-05-21
06945095544296zumaxBM800401E10202026-05-21
06945095544302zumaxSR24A418-18122026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095540106zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540113zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540120zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540410zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540427zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540434zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540441zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540458zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540465zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540472zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540489zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540496zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540502zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540519zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540526zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540533zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540540zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540557zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540564zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540571zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540588zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540595zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540601zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540618zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540625zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540632zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540649zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540656zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540670zumaxZumax Medical Co., LTDHJH2026-05-18
06945095540687zumaxZumax Medical Co., LTDHJH2026-05-18