DEVICE: MRI SeedNet®Gold Cryoablation System (07290104830020)

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Device Identifier (DI) Information

MRI SeedNet®Gold Cryoablation System
FPRCH2035
FPRCH2035
GALIL MEDICAL LTD
07290104830020
GS1
1
MRI Cryoablation System
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Device Characteristics

MR Conditional
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
General cryosurgical system, cryogen gas, electronic An assembly of mains electricity (AC-powered) devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal. The system typically includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, and sometimes to monitor skin temperature; and cryogen-cooled probes to apply the cold to tissues upon contact. It is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.
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FDA Product Code

[?]
Product Code Product Code Name
GEH Unit, Cryosurgical, Accessories
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 85 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 15, 2016

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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
No Package DIs found
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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
651-287-5000
galil.cst@btgplc.com
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