FDA.reportPublic FDA data

Gebauer's Ethyl Chloride Mist Spray

Primary DI
00303860001027
Brand
Gebauer's Ethyl Chloride Mist Spray
Company
GEBAUER COMPANY
Model
0386-0001-02
Catalog number
0386-0001-02
Device description
EC Mist Topical Anesthetic Spray
Published
2020-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLYRefrigerant, Topical (Vapocoolant)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLYVapocoolant DeviceUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190161000Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine SprayGebauer Company2019-05-07MLY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10303860001024PackageGS14In Commercial Distribution
20303860001021PackageGS112In Commercial Distribution
00303860001027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030386000102410303860001024
2030386000102120303860001021
00303860001027003038600010273038600010270303860001027

GMDN Terms#

Term, Definition table
TermDefinition
Cold/cool therapy sprayA non-sterile liquid (e.g., alcohol based) in a spray container intended for localized application to the body surface to provide a cooling effect for underlying muscles/joints to reduce pain and swelling typically from sports injuries (cold therapy), and/or for cooling at the skin surface to treat heat rash or hot flushes (cool therapy); it may be intended to be applied to the skin directly or used in combination with a moist-cold pack/bandage (i.e., used to soak the moist-cold pack/bandage). After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume116Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-321-9348information@gebauer.com

Regulatory Flags#

DUNS number
004166021
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00303860010012Gebauer's Instant Ice0386-0010-010386-0010-012020-02-27
00303860001119Gebauer's Ethyl Chloride Medium Spray Accu-Stream 3600386-0001-110386-0001-112020-02-27
00303860001133Gebauer's Ethyl Chloride Fine Spray Accu-Stream 360 0386-0001-130386-0001-132020-02-27
00303860004042Gebauer's Spray and Stretch0386-0004-040386-0004-042020-02-27
00303860008019Gebauer's Pain Ease Mist Spray0386-0008-010386-0008-012020-02-27
00303860008026Gebauer's Pain Ease Mist Spray0386-0008-020386-0008-022020-02-27
00303860008033Gebauer's Pain Ease Medium Stream0386-0008-030386-0008-032020-02-27
00303860008040Gebauer's Pain Ease Medium Stream0386-0008-040386-0008-042020-02-27
00303860001041Gebauer's Ethyl Chloride Fine Spray0386-0001-040386-0001-042020-02-27
20303860001113Gebauer's Ethyl Chloride Medium Spray Accu-Stream 3600386-0001-110386-0001-112020-02-27
20303860001137Gebauer's Ethyl Chloride Fine Spray Accu-Stream 360 0386-0001-130386-0001-132020-02-27
20303860004046Gebauer's Spray and Stretch0386-0004-040386-0004-042020-02-27
30303860008010Gebauer's Pain Ease Mist Spray0386-0008-010386-0008-012020-02-27
20303860008020Gebauer's Pain Ease Mist Spray0386-0008-020386-0008-022020-02-27
20303860008037Gebauer's Pain Ease Medium Stream0386-0008-030386-0008-032020-02-27
30303860008041Gebauer's Pain Ease Medium Stream0386-0008-040386-0008-042020-02-27
20303860010016Gebauer's Instant Ice0386-0010-010386-0010-012020-02-27
00303860001034Gebauer's Ethyl Chloride Medium Spray0386-0001-030386-0001-032020-02-19
10303860001031Gebauer's Ethyl Chloride Medium Spray0386-0001-030386-0001-032020-02-19

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