FDA.reportPublic FDA data

Lumitex MD 3.75mm ACMI Reusable Light Cable

Primary DI
00812432021559
Brand
Lumitex MD 3.75mm ACMI Reusable Light Cable
Company
Lumitex, Inc.
Model
005011
Catalog number
012678
Published
2026-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FDGRetractor, Fiberoptic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDGRetractor, FiberopticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812432021559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812432021559008124320215598124320215590812432021559

GMDN Terms#

Term, Definition table
TermDefinition
Open surgical site internal lightAn electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
108631797
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812432021504Alphatec Spine Illico Directional Illuminator008559735562020-09-28
00812432020705Alphatec Spine - Battalion LLIF Light Cable01185627436-22019-06-28
00812432023133Light Cable, Vaginal Retractor03.012.1400133172026-02-11
00812432022945Spineart Storz Cable AdaptorMIS-IN 44 50-N0086572023-08-11
00812432023164Medtronic 4mm Universal Reusable Light Cable0134212026-01-07
00812432023171Medtronic 4mm ACMI Cable Adapter0134222026-01-07
00812432023188Medtronic 4mm WOLF Cable Adapter0134232026-01-07
00812432023195Medtronic 4mm OLYMPUS Cable Adapter0134242026-01-07
00812432023201Medtronic 4mm STORZ Cable Adapter0134252026-01-07
00812432022396Spineart Wolf Cable AdaptorMIS-IN 44 20-N0086542023-08-11
00812432022921Spineart Olympus Cable AdaptorMIS-IN 44 30-N0086552023-08-11
00812432021689Lumitex 4mm Universal Fiber Optic Cable0121390126812023-08-11
00812432021696Lumitex 3.5mm Fiber Optic Cable0120040126822023-08-11
00812432022761Bones and Nerves 3.75mm Reusable Fiber Optic CableBNS-LT 10 03-N0126232023-08-11
00812432022778Alphatec Spine Wolf Cable Adaptor735510069642023-08-11
00812432022785Alphatec Spine Olympus Cable Adaptor735520069652023-08-11
00812432022792Alphatec Spine ACMI Cable Adaptor735530069662023-08-11
00812432022808Alphatec Spine Storz Cable Adaptor735540069672023-08-11
00812432022938Spineart ACMI Cable AdaptorMIS-IN 44 40-N0086562023-08-11
00812432020675SeaSpine Surgical Illuminator Cable00832991-84082022-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G425110676LSI0My MedicalMy Medical Store LLCFDG2026-05-04
G425110686LSI0My MedicalMy Medical Store LLCFDG2026-05-04
00812432023140Medtronic Surgical Illuminator - TubeLumitex, Inc.FDG2026-04-17
00812432023157Medtronic Surgical Illuminator - BladeLumitex, Inc.FDG2026-04-17
00812432023218Lumitex Surgical Tube IlluminatorLumitex, Inc.FDG2026-03-23
G4255721131S0My MedicalMy Medical Store LLCFDG2026-02-27
00812432023133Light Cable, Vaginal RetractorLumitex, Inc.FDG2026-02-11
00812432023164Medtronic 4mm Universal Reusable Light CableLumitex, Inc.FDG2026-01-07
00812432023171Medtronic 4mm ACMI Cable AdapterLumitex, Inc.FDG2026-01-07
00812432023188Medtronic 4mm WOLF Cable AdapterLumitex, Inc.FDG2026-01-07
00812432023195Medtronic 4mm OLYMPUS Cable AdapterLumitex, Inc.FDG2026-01-07
00812432023201Medtronic 4mm STORZ Cable AdapterLumitex, Inc.FDG2026-01-07
03662663273350Timberline Lateral Fusion SystemHighridge Medical, LLCFDG2025-12-18
00812432023072L&K Biomed BluEX Surgical IlluminatorLumitex, Inc.FDG2025-12-11
00888515328037BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2025-10-28
00888515328044BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2025-10-28
00812432023096Lumitex Surgical IlluminatorLumitex, Inc.FDG2025-10-23
008124320230654WEB Medical OA51S Surgical IlluminatorLumitex, Inc.FDG2025-04-08
00840183529512BR Surgical, LLCBR Surgical, LLCFDG2025-02-12
00812432023041Precision Spine TLIF Bifurcated Surgical IlluminatorLumitex, Inc.FDG2024-10-25
00812432023058Lattus Spine Surgical IlluminatorLumitex, Inc.FDG2024-06-21
00840183514235BR Surgical, LLCBR Surgical, LLCFDG2024-03-11
G4251106670My MedicalMy Medical Store LLCFDG2024-03-07
G425110679LS0My MedicalMy Medical Store LLCFDG2024-03-07
00840183525620BR Surgical, LLCBR Surgical, LLCFDG2024-03-04
00888515319363BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
00888515319417BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
00888515319424BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
00888515319431BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
10888515319360BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21