AccessGUDID - DEVICE: truFreeze (00724995199296)

GUDID

Device Identifier (DI) Information

Brand Name: truFreeze
Version or Model: CC301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CC301
Company Name: US Endoscopy

Primary DI Number: 00724995199296
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 627879687 *Terms of Use
Previous DI: 00857068006006

Device Description: truFreeze Spray Cryotherapy System Console allows for delivery of liquid nitrogen (LN2) during both active and passive venting procedures.

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?
11067	General cryosurgical system, cryogen gas, mechanical	An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEH	UNIT, CRYOSURGICAL, ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171626	000
K222272	000
K223369	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: 5fff537d-3e15-4730-9825-6fc0ffeba7e5
Public Version Date: July 19, 2023
Public Version Number: 1
DI Record Publish Date: July 11, 2023