DEVICE: IceRod® i-Thaw® Prostate Cryoablation Kit / Presice® System (07290104830105)
Device Identifier (DI) Information
IceRod® i-Thaw® Prostate Cryoablation Kit / Presice® System
FPRPR4070
Not in Commercial Distribution
FPRPR4070
GALIL MEDICAL LTD
FPRPR4070
Not in Commercial Distribution
FPRPR4070
GALIL MEDICAL LTD
Prostate Kit including Cryoablation Needles, Thermal Sensor, Urethral Warming Set, Prostate Template
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
45140 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEH | Unit, Cryosurgical, Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Cool, Dry, Place |
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 |
Device Record Status
0d6e4eb4-fee9-48ad-94eb-bf06ae0b4c66
November 07, 2022
7
August 15, 2016
November 07, 2022
7
August 15, 2016
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 |
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
[?]
651-287-5000
galil.cst@btgplc.com
galil.cst@btgplc.com