FDA.reportPublic FDA data

Gebauer's Instant Ice

Primary DI
20303860010016
Brand
Gebauer's Instant Ice
Company
GEBAUER COMPANY
Model
0386-0010-01
Catalog number
0386-0010-01
Device description
II Med Topical Skin Refrigerant
Published
2020-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
K021726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021726000GEBAUER'S INSTANT ICEGebauer Co.2002-12-12MLY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20303860010016PackageGS112In Commercial Distribution
00303860010012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2030386001001620303860010016
00303860010012003038600100123038600100120303860010012

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 Volume103.5Milliliter
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
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
00303860001034Gebauer's Ethyl Chloride Medium Spray0386-0001-030386-0001-032020-02-19
10303860001031Gebauer's Ethyl Chloride Medium Spray0386-0001-030386-0001-032020-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10723797170615InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170721InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170837InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
10723797170943InstaNumbBEUTLICH PHARMACEUTICALS, LLCMLY2026-04-15
00850079280298HexaHexa DentalMLY2026-01-21
10723797806446Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797807443Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797809447Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
20723797806443Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
20723797807440Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
10723797808440Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
20723797809444Hurri-FreezeBEUTLICH PHARMACEUTICALS, LLCMLY2025-12-15
00860010587355DentalJect ApplicatorVapocoolshot, IncMLY2025-11-07
00860010587362DentalJect Syringe ConnectorVapocoolshot, IncMLY2025-11-07
00860010587393DentalJect Starter Kit - No Syringe ConnectorVapocoolshot, IncMLY2025-11-07
00860010587348DentalJect CanisterVapocoolshot, IncMLY2025-09-08
00860010587379DentalJect Applicator SetVapocoolshot, IncMLY2025-09-08
00860010587386DentalJect Starter KitVapocoolshot, IncMLY2025-09-08
00860010587331CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
00860010587317CoolJect Targeted-Mist 1-3cc Nook Syringe Holder AccessoryVapocoolshot, IncMLY2025-08-01
00860010587324CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
10860010587321CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2025-08-01
00860006961596CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2023-04-28
00860006961589CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2023-04-28
10860006961586CoolJect Targeted-Mist Topical AnestheticVapocoolshot, IncMLY2023-04-28
10860006961524Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
20860006961521Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
00860006961527Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
00860006961503Coolject Topical Anesthetic CanisterVapocoolshot, IncMLY2023-01-27
00860006961510Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncMLY2023-01-27