AccessGUDID - DEVICE: ICEOUT™ (10607151012103)

GUDID

Device Identifier (DI) Information

Brand Name: ICEOUT™
Version or Model: CRY2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CRY2
Company Name: BOVIE MEDICAL CORPORATION

Primary DI Number: 10607151012103
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079940465 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEH	Unit, Cryosurgical, Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152203	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do Not Exposed to temperatures exceeding 20 degrees Celsius.
Special Storage Condition, Specify: Protect from Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ce00edd7-14f3-4ec7-8a79-3fafdd7409d5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 17, 2017