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.
10840143911750
GS1

1
006133784 *Terms of Use
Cryoablation Probe
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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
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FDA Product Code

[?]
Product Code Product Code Name
GXH Device, Surgical, Cryogenic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K233170 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
Length: 17 Inch
Outer Diameter: 10 Millimeter
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Device Record Status

2a4e01ae-c72c-4b56-9e47-3748e252716d
February 23, 2024
1
February 15, 2024
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
866-449-2342
SEhlert@atricure.com
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