Gebauer's Instant Ice

Basic Information

• Brand Name: Gebauer's Instant Ice
• Primary DI: 00303860010012
• Version / Model: 0386-0010-01
• Catalog Number: 0386-0010-01
• Company Name: GEBAUER COMPANY
• Labeler DUNS: 004166021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-27
• Public Version: 2
• Public Version Date: 2023-08-29
• Public Version Status: Update
• Public Device Record Key: aae0f02e-0b27-4eb2-9233-9db7700351b4

Device Description

II Med Topical Skin Refrigerant

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MLY	Refrigerant, Topical (Vapocoolant)	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46557	Cold/cool therapy spray	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20303860010016	GS1		12	In Commercial Distribution
Primary	00303860010012	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K021726	000

Device Sizes

Type	Value	Unit	Text
Total Volume	116	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 120 Degrees Fahrenheit