FDA.reportPublic FDA data

Fiber Optic Illuminator

Primary DI
00869836000345
Brand
Fiber Optic Illuminator
Company
I-Tek Medical, Inc.
Model
1090-001
Published
2019-05-28
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

Contact Domains#

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
10869836000342PackageGS11In Commercial Distribution
00869836000345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086983600034210869836000342
00869836000345008698360003458698360003450869836000345

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

Contacts#

Phone, Email table
PhoneEmail
651-454-6602info@i-tekmedical.com

Regulatory Flags#

DUNS number
080599644
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869836000314Fiber Optic Illuminator1136-0012018-12-06
00869836000321Fiber Optic Illuminator1102-0012019-05-28
00869836000307I-Tek I-150 LED Light SourceI-150I-1502017-06-23

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