FDA.reportPublic FDA data

Isolux llc

Primary DI
00852350007013
Brand
Isolux llc
Company
ISOLUX LLC
Model
FO-2088
Catalog number
05-09WS
Device description
Bifurcated Fiber Optic Headlight Cable, Wolf, Lensed, 3.8mm x 8.5ft, Long ACMI
Published
2016-11-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSTLight, Surgical, Fiberoptic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSTLight, Surgical, FiberopticGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852350007013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852350007013008523500070138523500070130852350007013

GMDN Terms#

Term, Definition table
TermDefinition
Fibreoptic light cableA flexible fibreoptic cable that is designed to transport cold light from a light source to an instrument or other equipment, e.g., an endoscope or a headlight. The fibreoptic bundle is protected within a sheath and can be made of either glass or plastic fibres. Each end of the cable is encased in a metal connector that fits into the respective instruments/equipment and also protects the end of the fibreoptic bundle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
239-514-7475nick@isoluxllc.com

Regulatory Flags#

DUNS number
828730973
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008523500070061300XSB1300XSB03-1300XSB2016-12-01
00852350007020OptiLux LED IlluminatorOptiLux2016-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00816835024452SYSTEM TWO LEDMedical Illumination International Inc.FST2026-04-30
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10845854040379CONMEDConmed CorporationFST2026-03-24
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00816835024346SM1Medical Illumination International Inc.FST2024-09-04
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00816835024322MI-1000CAMMedical Illumination International Inc.FST2024-08-19
00816835024339MI-1000CAMMedical Illumination International Inc.FST2024-08-19
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01816835024338MI-1000CAMMedical Illumination International Inc.FST2024-08-19
00840606184922Lucent LateralSPINAL ELEMENTS, INC.FST2024-08-13
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00816744027728NICO Myriad SPECTRANICO CORPORATIONFST2024-06-07