FDA.reportPublic FDA data

zumax

Primary DI
06945095544050
Brand
zumax
Company
Zumax Medical Co., LTD
Model
GL6030
Catalog number
473-1810
Published
2026-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJNTransilluminator, Battery-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJNTransilluminator, Battery-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945095544050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095544050069450955440506945095544050

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source unit, battery-poweredA battery-powered device designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes (e.g., laparoscopes, gastroscopes). It is typically designed as a portable endoscope attachment whereby the bright light is channelled to the endoscope to illuminate the site of observation/intervention while minimizing tissue heating. 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
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
06945095544326zumaxOT8D461-51132026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095543787zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544678zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544692zumaxZumax Medical Co., LTDHJN2026-05-21
B945BERAI0BernellBernellHJN2026-05-02
B945MTBIFL0BernellBernellHJN2026-05-02
B945MTBIH20BernellBernellHJN2026-05-02
00697077003166Amico Diagnostic IlluminatorAmico Diagnostic IncorporatedHJN2026-02-24
00697077003173Amico Diagnostic IlluminatorAmico Diagnostic IncorporatedHJN2026-02-24
04053755202973FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJN2025-07-17
00850064466348VF1000LED Vein locatorFABINJECT LLCHJN2025-03-02
00850038195564EZ-TRI-3600U.S. OPHTHALMIC, L.L.C.HJN2025-02-19
07898915128789VF1000LED Vein locatorFABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAHJN2024-06-07
00732094074130Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094074185Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094074192Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082708Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082715Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
00732094082739Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-08-17
04260114140214ASTODIAStihler Electronic GmbHHJN2023-07-18
00850018561099Wee Sight Transilluminator INTERNATIONAL BIOMEDICAL, LTD.HJN2023-06-20
00732094084207Welch Allyn, Inc.WELCH ALLYN, INC.HJN2023-04-25
04053755119943OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJN2022-12-21
04053755120109OPHTHALMIC EXAMINATION LAMPHeine Optotechnik GmbH & Co. KGHJN2022-12-21
04053755200429FINOFF TRANSILLUMINATORHeine Optotechnik GmbH & Co. KGHJN2022-12-21
00732094082722Welch Allyn, Inc.WELCH ALLYN, INC.HJN2021-07-12
10812594013000NeoGlo DisposableNeotech Products LLCHJN2021-05-20
10812594013062NeoGlo DisposableNeotech Products LLCHJN2021-05-20
00812594012716NeoGlo®Neotech Products LLCHJN2021-05-20
00812594013003NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20
00812594013065NeoGlo DisposableNEOTECH PRODUCTS, INC.HJN2021-05-20