Freezpen

Basic Information

• Brand Name: Freezpen
• Primary DI: B386CLN2O8GBOX1
• Version / Model: 8g N2O cartridges for Freezpen
• Catalog Number: CL-N2O-8G-BOX
• Company Name: H & O Equipments SA
• Labeler DUNS: 370212933
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 38734934-6f34-49e5-856d-21864d276097

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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
60509	Nitrous oxide gas cartridge	A small sealed cylinder containing pressurized nitrous oxide (N2O) gas intended to be inserted into a parent device (e.g., cryosurgical system) where the cylinder is perforated to release the gas, which typically serves as a refrigerant (Joule-Thomson effect). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B386CLN2O8GCARTON2	HIBCC		16	In Commercial Distribution
Primary	B386CLN2O8GBOX1	HIBCC
Unit of Use	B386CLN2O8GBOX0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K024009	000