Gebauer's Instant Ice 0386-0010-01

GUDID 20303860010016

II Med Topical Skin Refrigerant

GEBAUER COMPANY

Cold/cool therapy spray
Primary Device ID20303860010016
NIH Device Record Keyaae0f02e-0b27-4eb2-9233-9db7700351b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameGebauer's Instant Ice
Version Model Number0386-0010-01
Catalog Number0386-0010-01
Company DUNS004166021
Company NameGEBAUER COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com
Phone800-321-9348
Emailinformation@gebauer.com

Device Dimensions

Total Volume103.5 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter
Total Volume116 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100303860010012 [Primary]
GS120303860010016 [Package]
Contains: 00303860010012
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MLYRefrigerant, Topical (Vapocoolant)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-06
Device Publish Date2020-02-27