AccessGUDID - DEVICE: AtriCure cryoICE cryoSPHERE Cryoablation System (00818354016321)

GUDID

Device Identifier (DI) Information

Brand Name: AtriCure cryoICE cryoSPHERE Cryoablation System
Version or Model: CRYOS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: A001009
Company Name: ATRICURE, INC.

Primary DI Number: 00818354016321
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006133784 *Terms of Use

Device Description: CRYOS, Packaged Assembly

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":	Yes
For Single-Use:	Yes
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
GXH	Device, Surgical, Cryogenic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182565	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -28 and 37 Degrees Celsius
Storage Environment Temperature: between -20 and 100 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 8 Millimeter

Device Record Status

Public Device Record Key: 418884ad-a44a-48f0-bf57-354de7a42b1e
Public Version Date: April 07, 2021
Public Version Number: 3
DI Record Publish Date: November 15, 2018