FDA.reportPublic FDA data

Choice Spine Surgical Illuminator

Primary DI
00812432022167
Brand
Choice Spine Surgical Illuminator
Company
Lumitex, Inc.
Model
007123
Catalog number
500-9610
Published
2020-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00812432022167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812432022167008124320221678124320221670812432022167

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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
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
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
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
10888515319360BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
10888515319414BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
10888515319421BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
10888515319438BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
00888515319455BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
00888515319462BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-21
10888515319476BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FDG2024-02-20
00190376508085ATEC Light Cable SystemALPHATEC SPINE, INC.FDG2024-02-02
00190376508092ATEC Light Cable SystemALPHATEC SPINE, INC.FDG2024-02-02
00840183513887BR Surgical, LLCBR Surgical, LLCFDG2024-02-01