AccessGUDID - DEVICE: Freezpen (B386CLN2O8GBOX1)

GUDID

Device Identifier (DI) Information

Brand Name: Freezpen
Version or Model: 8g N2O cartridges for Freezpen
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CL-N2O-8G-BOX
Company Name: H & O Equipments SA

Primary DI Number: B386CLN2O8GBOX1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 15
Labeler D-U-N-S® Number*: 370212933 *Terms of Use

Device Description: No description.

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:	Yes
Prescription Use (Rx):	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEH	Unit, Cryosurgical, Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K024009	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 38734934-6f34-49e5-856d-21864d276097
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016