FDA.reportPublic FDA data

Gebauer's Spray and Stretch

Primary DI
20303860004046
Brand
Gebauer's Spray and Stretch
Company
GEBAUER COMPANY
Model
0386-0004-04
Catalog number
0386-0004-04
Device description
SS 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
OTC
false
Sterile
false
Single use
false

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
K031036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031036000GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03Gebauer Co.2003-07-10MLY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20303860004046PackageGS112In Commercial Distribution
00303860004042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030386000404620303860004046
00303860004042003038600040423038600040420303860004042

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00303860001027Gebauer's Ethyl Chloride Mist Spray0386-0001-020386-0001-022020-02-27
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
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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