FDA.reportPublic FDA data

zumax

Primary DI
06945095542056
Brand
zumax
Company
Zumax Medical Co., LTD
Model
SLT
Catalog number
50T-2546
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
06945095542056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095542056069450955420566945095542056

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945095541110zumaxSLE50E-25462026-06-03
06945095541424zumaxSLT50BS25422026-06-03
06945095541448zumaxSLF50F-25422026-06-03
06945095541455zumaxHL8200572-00602026-06-03
06945095541929zumaxSLT50T-3050-312026-06-03
06945095541936zumaxSLT50T-30502026-06-03
06945095541943zumaxSLT50T-30462026-06-03
06945095541950zumaxSLT50T-30342026-06-03
06945095541967zumaxSLT50T-30342026-06-03
06945095541974zumaxSLT50T-30462026-06-03
06945095541981zumaxSLT50T-30502026-06-03
06945095541998zumaxSLT50T-30462026-06-03
06945095542001zumaxSLT50T-30342026-06-03
06945095542018zumaxSLT50T-3042-312026-06-03
06945095542025zumaxSLT50T-30422026-06-03
06945095542032zumaxSLT50T-30422026-06-03
06945095542049zumaxSLT50T-25502026-06-03
06945095542063zumaxSLT50T-25422026-06-03
06945095542070zumaxSLT50T-25342026-06-03
06945095542087zumaxSLT50T-25462026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095541110zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541424zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541448zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541929zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541936zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541943zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541950zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541967zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541974zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541981zumaxZumax Medical Co., LTDHJH2026-06-03
06945095541998zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542001zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542018zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542025zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542032zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542049zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542063zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542070zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542087zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542094zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542100zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542117zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542124zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542131zumaxZumax Medical Co., LTDHJH2026-06-03
06945095542148zumaxZumax Medical Co., LTDHJH2026-06-03
06945095543732zumaxZumax Medical Co., LTDHJH2026-06-03
06945095544289zumaxZumax Medical Co., LTDHJH2026-06-03
06945095544722zumaxZumax Medical Co., LTDHJH2026-06-03
06945095548096zumaxZumax Medical Co., LTDHJH2026-06-03
06945095548102zumaxZumax Medical Co., LTDHJH2026-06-03