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Found 19 results
510(k) Data Aggregation
K Number
K142473Device Name
Lubricating Jelly
Manufacturer
SION BIOTEXT MEDICAL LTD
Date Cleared
2015-04-13
(222 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Product Code :
KMJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when either sterile or non-sterile fields are required.
Device Description
Sion's Lubricating Jelly is used to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when either sterile or non-sterile fields are required. Typical uses of the lubricating jelly include (but not limited) insertion of catheters, endoscopes surgical instruments, gynecological, rectal, oral and rubber or plastic etc. The lubricating jelly is clear, greaseless, odorless, water soluble and non-irritating to the skin, tissue and mucous membranes. Both product types (sterile and non-sterile) are packed in a bacterial barrier tubes or sealed laminated sachets. Sion's Lubricating Jelly is a body contact material and was evaluated for biocompatibility with accordance to FDA's Memorandum - #G95 1, May 1, 1995 and ISO 10993-1:2009.
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K Number
K141028Device Name
COLONGLIDE LUBRICANT
Manufacturer
PEDIATRIC PHARMACEUTICALS INC.
Date Cleared
2014-07-24
(93 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Product Code :
KMJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K131617Device Name
COLONGLIDE(R) LUBRICANT
Manufacturer
PEDIATRIC PHARMACEUTICALS, INC.
Date Cleared
2013-10-03
(122 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Product Code :
KMJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Colonglide® Lubricant Is indicated for medical purposes for use to lubricate a body orifice of a patient in order to facilitate the entry of a diagnostic or therapeutic medical device (such as an endoscope). This device is intended for use on order of a physician.
Device Description
Colonglide® Lubricant is a clear, colorless, non-sterile, odorless, water-based patient lubricant. The subject device is packaged for individual use in a 250 mL round plastic bottle sealed with a screw cap with a foil induction innerseal liner.
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K Number
K121390Device Name
LUBE JELLY SURINGE
Manufacturer
NURSE ASSIST, INC.
Date Cleared
2012-08-10
(93 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Product Code :
KMJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Prescription Use: For easing the insertion of medical devices such as scopes and catheters into body orifices.
Device Description
The subject device is a terminally gamma sterilized 10cc polypropylene plastic syringe filled with United Guardian lubricating jel and capped with a polypropylene plastic cap. United Guardian has a Master File Reference for its lubrication jel, Master File for Devices MAF-613 pertaining to Lubrajel RR. All components of the device are gamma irradiation stable.
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K Number
K113689Device Name
DUKAL LUBRICATING JELLY
Manufacturer
DUKAL CORPORATION
Date Cleared
2012-05-04
(141 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Product Code :
KMJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dukal Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic devices when a sterile field is required.
Device Description
The Dukal Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly.
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K Number
K112110Device Name
STERILE LUBRICATING JELLY
Manufacturer
JIANERKANG MEDICAL DRESSING COMPANY
Date Cleared
2012-04-10
(263 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Product Code :
KMJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Jianerkang Sterile Lubricating Jelly is intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.
Device Description
The Jianerkang Sterile Lubricating Jelly is a clear, greaseless, watersoluble sterile lubricating jelly.
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K Number
K103718Device Name
DYNACOR LUBRICATION GEL
Manufacturer
MEDLINE INDUSTRIES, INC.
Date Cleared
2011-05-10
(140 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Product Code :
KMJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Device Description
Not Found
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K Number
K101522Device Name
ULTRA SEAL STERILE LUBRICATING JELLY
Manufacturer
ULTRA SEAL CORPORATION
Date Cleared
2010-12-23
(204 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Product Code :
KMJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For lubrication to provide easy insertion of catheters, endoscopes, or gloved fingers into bodily orifices. The device is intended for use on order of a physician. Non-prescription over-the-counter use.
Device Description
Ultra Seal Sterile Lubricating Jelly patient lubricant is a water- based, clear, colorless, 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 or packet is terminally sterilized by gamma radiation. The product is sterile unless package is opened, damaged, or the seal for the packet product is not intact, with label directions to discard after use.
The product is packaged in a convenient 2 oz., 4.0 oz., and 4.2 oz aluminum tube with a cap and a puncture seal blind, or a 2 oz., 4.0 oz., and 4.2 oz foil laminate tube with a flip top and a peel seal, and 3 and 5 gram laminated film packets, the lamination being paper, polyethylene, foil, polyethylene. All tube configurations contain an aluminum barrier to preserve the product's properties and sterility. Stability has been performed on all tubes and packets and data from 3 months of accelerated studies supports an initial expiration term of 24 months from the date of manufacture. Expiration dating will be confirmed through concurrent room temperature stability studies.
This product is not a contraceptive and does not contain a spermicide.
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K Number
K092488Device Name
DYNAREX STERILE LUBRICATING JELLY
Manufacturer
DYNAREX CORPORATION
Date Cleared
2009-12-18
(127 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Product Code :
KMJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dynarex Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.
Device Description
Dynarex Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly. Typical packaging configurations for the Dynarex Sterile Lubricating Jelly is 3 g or 5 g foil packs, and 2 oz or 4 oz tubes, Other sizes may become available.
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K Number
K083189Device Name
STERI-LUB LUBRICATION GEL
Manufacturer
AVAIL MEDICAL PRODUCTS, INC.
Date Cleared
2008-11-21
(23 days)
Product Code
KMJ
Regulation Number
880.6375Why did this record match?
Product Code :
KMJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Steri-Lub Lubricating Gel is intended to be used in procedures requiring a sterile product (surgical and urological). The Lubrication Gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
Device Description
The Steri-LubTM Lubrication Gel is a sterile, single patient use, disposable instrument that is substantially equivalent to the predicate device and other pre-filled syringes. All Steri-Lubrication Gel syringes are designed for lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device only and are intended for single patient use.
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