FDA.reportPublic FDA data

Koros Surgical Illuminator

Primary DI
00812432022952
Brand
Koros Surgical Illuminator
Company
Lumitex, Inc.
Model
7776-25
Catalog number
012691
Published
2023-08-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
00812432022952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812432022952008124320229528124320229520812432022952

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.

Regulatory Flags#

DUNS number
108631797
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812432022747Bones and Nerves Disposable Single Leg Surgical IlluminatorBNS-LT 10 01-S0126202023-08-11
00812432022754Bones and Nerves Surgical Solutions Disposable Bifurcated Surgical IlluminatorBNS-LT 10 02-S0126222023-08-11
00843210144184Altus Spine Bifurcated Illuminator012031610-35002020-09-28
00812432020187Lumitex ACMI Fiber Optic Cable0050110050112019-07-05
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
00812432021559Lumitex MD 3.75mm ACMI Reusable Light Cable0050110126782026-01-29
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

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
00812432021559Lumitex MD 3.75mm ACMI Reusable Light CableLumitex, Inc.FDG2026-01-29
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