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Gebauer Co.

Last updated September 17, 2026

Information

Country: US
Address: 4444 E. 153RD ST., Cleveland, OH, 44128
Website: —
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Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1519179
DUNS Number: —

Catalogue (21)

Device	Model / Reference	Registries	Class	Status
Gebauer's Ethyl Chloride Fine Spray Accu-Stream 360	0386-0001-13	FDA UDI	U	Active
Gebauer's Pain Ease Medium Stream	0386-0008-03	FDA UDI	U	Active
Gebauer's Pain Ease Mist Spray	0386-0008-02	FDA UDI	U	Active
Gebauer's Ethyl Chloride Fine Spray	0386-0001-04	FDA UDI	U	Active
Gebauer's Spray and Stretch	0386-0004-04	FDA UDI	U	Active
Gebauer's Ethyl Chloride Medium Spray Accu-Stream 360	0386-0001-11	FDA UDI	U	Active
Gebauer's Ethyl Chloride Mist Spray	0386-0001-02	FDA UDI	U	Active
Gebauer's Instant Ice	0386-0010-01	FDA UDI	U	Active
Gebauer's Pain Ease Mist Spray	0386-0008-01	FDA UDI	U	Active
Gebauer's Pain Ease Medium Stream	0386-0008-04	FDA UDI	U	Active
Gebauer's Ethyl Chloride Medium Spray	0386-0001-03	FDA UDI	U	Active
Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25	K981693	FDA 510(k)	U	Active
Gebauer's Skin Refrigerant (mist Stream), Gebauer's Skin Refrigerant (stream Spray), Models P/N 0386-0010-07	K032671	FDA 510(k)	U	Active
Gebauer's Chloride Fine Nozze	K991514	FDA 510(k)	U	Active
Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)	K172028	FDA 510(k)	U	Active
Fluori Methane Ss- A Vapocoolant/Skin Ref. Device	K930915	FDA 510(k)	U	Active
Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray	K190161	FDA 510(k)	U	Active
Gebauer's Fluori-Methane, Model 0386-0003-04	K001624	FDA 510(k)	U	Active
Gebauer's Skin Refrigerant (mist Spray), Model P/N 0386-0010-07, Gebauer's Skin Refrigerent (medium Spray), Model P/N-03	K031036	FDA 510(k)	U	Active
Gebauer's Fluro Ethyl, Model 0386-0002-09	K002596	FDA 510(k)	U	Active
Gebauer's Instant Ice	K021726	FDA 510(k)	U	Active

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FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 3, 2008	Z-0218-2009	—	terminated	Some units of Fluro-Ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the normal inverted position from the product's actuator. The product can also leak coolant from the side of the valve onto the fingers of the user.
Apr 17, 2007	Z-1062-2007	—	terminated	Mold contamination
Apr 17, 2007	Z-1059-2007	—	terminated	Mold contamination
Apr 17, 2007	Z-1057-2007	—	terminated	Mold contamination
Apr 17, 2007	Z-1058-2007	—	terminated	Mold contamination
Apr 17, 2007	Z-1061-2007	—	terminated	Mold contamination
Apr 17, 2007	Z-1060-2007	—	terminated	Mold contamination
Jan 19, 2007	Z-0497-2007	—	terminated	Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing.
Feb 23, 2004	Z-0641-04	—	terminated	The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty.