FDA.reportPublic FDA data

zumax

Primary DI
06945095545231
Brand
zumax
Company
Zumax Medical Co., LTD
Model
HL8350
Catalog number
552-9010
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBALight, Surgical Headlight

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBALight, Surgical HeadlightDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945095545231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095545231069450955452316945095545231

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn lampAn electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.

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
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
06945095542056zumaxSLT50T-25462026-06-03
06945095542063zumaxSLT50T-25422026-06-03
06945095542070zumaxSLT50T-25342026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095541455zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548157zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548317zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548454zumaxZumax Medical Co., LTDEBA2026-06-03
06945095548515zumaxZumax Medical Co., LTDEBA2026-06-03
06945095546931zumaxZumax Medical Co., LTDEBA2026-06-01
06945095546993zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547037zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547204zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547433zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547440zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547778zumaxZumax Medical Co., LTDEBA2026-06-01
06945095547938zumaxZumax Medical Co., LTDEBA2026-06-01
06945095544258zumaxZumax Medical Co., LTDEBA2026-05-20
06945095544449zumaxZumax Medical Co., LTDEBA2026-05-20
06945095544623zumaxZumax Medical Co., LTDEBA2026-05-20
06945095544883zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545019zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545033zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545040zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545057zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545217zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545521zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545538zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545569zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545729zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545903zumaxZumax Medical Co., LTDEBA2026-05-20
06945095545934zumaxZumax Medical Co., LTDEBA2026-05-20
06945095546054zumaxZumax Medical Co., LTDEBA2026-05-20
06945095546177zumaxZumax Medical Co., LTDEBA2026-05-20