FDA.reportPublic FDA data

zumax

Primary DI
06945095540229
Brand
zumax
Company
Zumax Medical Co., LTD
Model
HL8000
Catalog number
556-0080
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
EBALight, Surgical Headlight

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBALight, Surgical HeadlightDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945095540229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095540229069450955402296945095540229

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
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
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
06945095545231zumaxZumax 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
06945095546238zumaxZumax Medical Co., LTDEBA2026-05-20
06945095546535zumaxZumax Medical Co., LTDEBA2026-05-20
06945095546566zumaxZumax Medical Co., LTDEBA2026-05-20
06945095546672zumaxZumax Medical Co., LTDEBA2026-05-20
06945095540205zumaxZumax Medical Co., LTDEBA2026-05-18
06945095540212zumaxZumax Medical Co., LTDEBA2026-05-18
06945095540236zumaxZumax Medical Co., LTDEBA2026-05-18
06945095540946zumaxZumax Medical Co., LTDEBA2026-05-18
06945095541912zumaxZumax Medical Co., LTDEBA2026-05-18
00615375014158Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-09
00615375014165Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-09
00615375014172Spark™ TruColor™METREX RESEARCH, LLCEBA2026-02-09