FDA.reportPublic FDA data

Boss Instruments LightMat Surgical Illuminator

Primary DI
10812432020085
Brand
Boss Instruments LightMat Surgical Illuminator
Company
LUMITEX, INC.
Model
012118
Catalog number
UA2550
Published
2019-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
10812432020085PackageGS15In Commercial Distribution
00812432020088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081243202008510812432020085
00812432020088008124320200888124320200880812432020088

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument fibreoptic lightA sterile device with a fibreoptic bundle core designed to be affixed to the surface of a surgical instrument, typically a retractor, to conduct cold light from a connected fibreoptic light cable and light source into a surgical wound for illumination during a surgical intervention. It typcially emits cold light only through its tip to eliminate glare, and may have a self-adhesive coating for attachment to the surgical instrument. This is a single-use device.

Sterilization Methods#

Method table
Method

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
true
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
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
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

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