AccessGUDID - DEVICE: Histofreezer (00850077006104)

GUDID

Device Identifier (DI) Information

Brand Name: Histofreezer
Version or Model: 1001-0295
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 36M1C
Company Name: CRYOCONCEPTS, LP

Primary DI Number: 00850077006104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 038024868 *Terms of Use

Device Description: Histofreezer, Kit, U.S., 36M1C The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.

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:	Yes
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 [?]
K990877	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: Protect form sunlight.
Handling Environment Temperature: less than 50 Degrees Celsius
Storage Environment Temperature: less than 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fd80ec73-f974-45da-9980-fd0e9c71ee8f
Public Version Date: April 07, 2021
Public Version Number: 2
DI Record Publish Date: September 22, 2020