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510(k) Data Aggregation
K Number
K081990Device Name
LUBRICANO STERILE GEL
Manufacturer
FARCO PHARMA GMBH
Date Cleared
2008-12-05
(144 days)
Product Code
FHX
Regulation Number
876.1500Why did this record match?
Product Code :
FHX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile gel for human use, e.g. in medical procedures - to aid the introduction of catheters and endoscopic instruments in transurethral examinations, and in intermittent catheterization - particularly for incontinence treatment.
Device Description
Lubricano® Sterile Gel is a sterile, water-soluble gel composed of hydroxyethylcellulose, glycerol, and purified water, which is contained in a 10 mL syringe. Lubricano® Sterile Gel is free from fats, latex, disinfectants and preservatives. Lubricano® Sterile Gel ensures that catheters and instruments move easily, and it adheres well to the mucosa.
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