ICEOUT™

Basic Information

• Brand Name: ICEOUT™
• Primary DI: 10607151012103
• Version / Model: CRY2
• Catalog Number: CRY2
• Company Name: BOVIE MEDICAL CORPORATION
• Labeler DUNS: 079940465
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-17
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ce00edd7-14f3-4ec7-8a79-3fafdd7409d5

Device Description

ICEOUT PORTABLE CRYOSURGICAL SYSTEM, (2) 80 ML AEROSOL DISPENSERS AND (60) 2 MM APPLICATORS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	878.4350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44724	Cryogenic spray, cutaneous	A refrigerant (e.g., dimethyl ether and propane) typically contained in an aerosol dispenser and intended to be used to freeze superficial skin lesions (e.g., warts) for their destruction and removal. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10607151012103	GS1

Premarket Submissions

Submission Number	Supplement Number
K152203	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Exposed to temperatures exceeding 20 degrees Celsius.
• Type: Special Storage Condition, Specify
• Special Conditions: Protect from Sunlight