BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

ClariFix

DI: 00850002250411 · Model: CFX-2002 · ENTELLUS MEDICAL, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

Basic Information

Brand Name: ClariFix
Primary DI: 00850002250411
Version / Model: CFX-2002
Company Name: ENTELLUS MEDICAL, INC.
Labeler DUNS: 017283879
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2020-09-01
Public Version: 4
Public Version Date: 2023-07-06
Public Version Status: Update
Public Device Record Key: 7fff9163-ec30-4ca1-a4b6-b22993ee2218

Device Description

Cryogen Canister

Device Characteristics

Single Use: Yes
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: Yes
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
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
Primary	00850002250411	GS1

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: – 50 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: – 50 Degrees Celsius