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510(k) Data Aggregation
K Number
K032671Device Name
GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07
Manufacturer
GEBAUER CO.
Date Cleared
2004-03-17
(201 days)
Product Code
MLY, DEV
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GEBAUER CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic: a vapocoolant (skin refrigerant) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passageways and the lips) and minor open wounds. Gebauer's Skin Refrigerant controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses, and sutures), injections (venipuncture, IV starts, cosmetic procedures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). The Medium Spray is also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.
Device Description
Gebauer's Skin Refrigerant (Mist and Medium Spray) Topical Anesthetic is a prescription device designed to deliver 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,2-Tetrafluoroethane) in a mist and medium spray. This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device delivery system is specifically designed to deliver a medium and mist spray of the Gebauer's Skin Refrigerant (Mist Spray and Stream Spray) mixture. The medium and mist spray is an appropriate mode of application when users follow directions for use, cooling the skin through rapid evaporation of the non-medicated volatile propellants.
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K Number
K031036Device Name
GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03
Manufacturer
GEBAUER CO.
Date Cleared
2003-07-10
(100 days)
Product Code
MLY, REF
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GEBAUER CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic: a vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections (venipuncture, IV starts) and the temporary relief of minor sports injuries. The Medium Spray is also intended for the treatment of restricted motion associated with myofascial pain caused by trigger points.
Device Description
Gebauer's Skin Refrigerant (Mist and Medium Spray) Topical Anesthetic is a prescription device designed to deliver 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,1,2-Tetrafluoroethane) in a mist and medium spray. This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device delivery system submitted in this application is specifically designed to deliver a medium and mist spray of the Gebauer's Skin Refrigerant (Mist Spray and Stream Spray) mixture. The medium and mist is an appropriate mode of application when users follow the labeled directions for use, cooling skin through rapid evaporation of the non-medicated volatile propellants.
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K Number
K021726Device Name
GEBAUER'S INSTANT ICE
Manufacturer
GEBAUER CO.
Date Cleared
2002-12-12
(202 days)
Product Code
MLY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GEBAUER CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gebauer's Instant Ice TM (Mist Spray): Use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries.
Gebauer's Instant Ice TM (Stream Spray): Use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries and muscle spasms.
Device Description
Gebauer's Instant Ice ™ (Mist Spray and Stream Spray) is an over-the-counter device to deliver 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,1,2-Tetrafluoroethane) in a stream or mist spray. This mixture self-propels itself from the delivery system without the need for a propellant, because of the mixtures high vapor pressure. This form of delivery is an appropriate mode of application when the consumer follows the labeled directions for use, cooling skin through rapid evaporation of non-medicated volatile propellants.
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K Number
K981693Device Name
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
Manufacturer
GEBAUER CO.
Date Cleared
2001-08-06
(1181 days)
Product Code
LFD
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GEBAUER CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An oral moisturizer which temporarily relieves the discomfort of dry mouth (xerostomia) and dry throat naturally. Salivart may be used to replace human saliva, when the amount of saliva normally secreted has been reduced. Salivart lubricates the mouth and throat to soothe discomfort and assist in speaking and swallowing. Salivart relieves dry mouth caused by certain medications, therapeutic treatments, diseases, normal aging and emotional factors.
Device Description
Salivart Oral Moisturizer, an OTC device, is an aqueous electrolyte solution containing a viscosity agent and an emulsifier. The solution is aerosolized with a nitrogen propellant. It comes in two different can sizes. The smaller size is both sold and used as a promotional sample.
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K Number
K002596Device Name
GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09
Manufacturer
GEBAUER CO.
Date Cleared
2001-02-15
(178 days)
Product Code
MLY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GEBAUER CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001624Device Name
GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04
Manufacturer
GEBAUER CO.
Date Cleared
2001-01-25
(244 days)
Product Code
MLY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GEBAUER CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K991514Device Name
GEBAUER'S CHLORIDE FINE NOZZE
Manufacturer
GEBAUER CO.
Date Cleared
1999-07-16
(77 days)
Product Code
MLY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
GEBAUER CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gebauer's Ethyl Chloride (Fine and Medium Nozzles): Gebauer's Ethyl Chloride is a vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections and the temporary relief of minor sports injuries. It is also intended for the treatment of restricted motion associated with myofascial pain caused by trigger points.
Device Description
Ethyl Chloride (Fine or Medium Nozzle) is a prescription device consisting of a single organic chemical (Ethyl Chloride) and a precise delivery system. The chemical is selfaerosolized to deliver a pinpoint stream spray.
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