DEVICE: AtriCure cryoICE cryoSPHERE MAX Cryoablation System (10840143911750)
Device Identifier (DI) Information
AtriCure cryoICE cryoSPHERE MAX Cryoablation System
CRYOSMAX-L
In Commercial Distribution
A001450
ATRICURE, INC.
CRYOSMAX-L
In Commercial Distribution
A001450
ATRICURE, INC.
Cryoablation Probe
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 [?] |
---|---|
K233170 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -29 and 60 Degrees Celsius |
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 17 Inch |
Outer Diameter: 10 Millimeter |
Device Record Status
2a4e01ae-c72c-4b56-9e47-3748e252716d
February 23, 2024
1
February 15, 2024
February 23, 2024
1
February 15, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
30840143911754 | 1 | 10840143911750 | In Commercial Distribution | Box | |
50840143911758 | 1 | 30840143911754 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
866-449-2342
SEhlert@atricure.com
SEhlert@atricure.com