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510(k) Data Aggregation
K Number
K073684Device Name
SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL
Manufacturer
SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD.
Date Cleared
2008-05-22
(146 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Applicant Name (Manufacturer) :
SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Patient lubricant intended for medical purposes to lubricate orifices to facilitate the entry of diagnostic and therapeutic devices. The device is intended for use on order of a physician.
Device Description
Sheffield Pharmaceuticals Sterile LubriGel patient lubricant is a waterbased, clear, colorless, odorless, non-sticky, non-greasy, non-staining, nonirritating patient lubricant. It is a water soluble, high viscosity gel-like liquid for use as patient lubricant when a sterile field is required. Each tube is terminally sterilized. The product is sterile unless package is opened or damaged with label directions to discard after use.
The product is packaged in a convenient 4.0 oz laminate tube with a flip top cap and peel seal.
This product is not a contraceptive and does not contain a spermicide.
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