FDA.reportPublic FDA data

LUMINDEX

Primary DI
04719873921775
Brand
LUMINDEX
Company
DENTMATE TECHNOLOGY CO., LTD.
Model
LUMINDEX 3
Device description
LUMINDEX 3 (Dentmate)
Published
2019-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
04719873921775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873921775047198739217754719873921775

GMDN Terms#

Term, Definition table
TermDefinition
Visible-light skin transilluminatorAn electrically-powered device intended to use visible light (e.g., red LED light) to illuminate the skin and subcutaneous soft tissues, rendering them translucent for examination. It is typically used to help locate peripheral veins beneath the skin to assist a healthcare professional during venipuncture or sclerotherapy, or for examining subcutaneous and scrotal tissue/contents for lesions or anatomical abnormalities. It is typically a portable hand-held device which may also be known as a vein finder/viewer, diaphanoscope, phaneroscope, or light scanner.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
656134660
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719873922215LEDEXWL-1202023-08-31
04719873922444LEDEXWL-1202023-08-31
04719873921447LUMINDEXLUMINDEX 32019-07-17
04719873921782LUMINDEXLUMINDEX 32019-07-17
04719873920082LEDEXWL-0702019-07-16
04719873920099LEDEXWL-0702019-07-16
04719873920105LEDEXWL-0702019-07-16
04719873920112LEDEXWL-0702019-07-16
04719873920129LEDEXWL-0702019-07-16
04719873920136LEDEXWL-0702019-07-16
04719873920143LEDEXWL-0702019-07-16
04719873920679LEDEXWL-070+2019-07-16
04719873920686LEDEXWL-070+2019-07-16
04719873920693LEDEXWL-070+2019-07-16
04719873920709LEDEXWL-070+2019-07-16
04719873920716LEDEXWL-070+2019-07-16
04719873920723LEDEXWL-070+2019-07-16
04719873920730LEDEXWL-070+2019-07-16
04719873921461LUMINDEXLUMINDEX 52019-07-17
04719873920471LEDEXWL-0902019-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095543787zumaxZumax Medical Co., LTDHJN2026-05-21
06945095544050zumaxZumax 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