DEVICE: IceSeed® Prostate Cryoablation Kit / SeedNet® System (07290104830068)

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Device Identifier (DI) Information

IceSeed® Prostate Cryoablation Kit / SeedNet® System
FPRPR3008
FPRPR3008
GALIL MEDICAL LTD
07290104830068
GS1
1
Prostate Kit including Cryoablation Needles, Thermal Sensors, Urethral Warming Set, Prostate Template
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Cryosurgical set A sterile collection of disposable devices used in conjunction with a cryosurgical unit as well as monitoring and other devices to perform a surgical technique that involves freezing a targeted area of tissue to damage and destroy cancer cells in the unwanted portions. A typical set will contain cryo needles, thermal sensors, warmer tubes and catheters, warmer cassette, and tube holders. It is typically used for early stages of prostate cancer or late recurrence of localized prostate cancer after radiotherapy where the prostate is cooled to a temperature of -40° Celsius. Warming of the areas where freezing is not required is simultaneously carried out. This is a single-use device.
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FDA Product Code

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

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

[?]
Storage and Handling
Special Storage Condition, Specify: Cool, Dry, Place
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Kit including: Cryoablation Needles and Sensors - 1.5 mm Shaft Diameter; 175 mm Shaft Length; Urethral Warming Set
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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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

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