SynchroWave Antenna Kit SW-1425

GUDID 00851551005156

25cm Long Tip Antenna and Cooling Circuit

PERSEON CORPORATION

Microwave ablation system probe
Primary Device ID00851551005156
NIH Device Record Keya370fc7a-f2bf-45e6-a56e-cb820b11c648
Commercial Distribution StatusIn Commercial Distribution
Brand NameSynchroWave Antenna Kit
Version Model NumberSW-1425
Catalog NumberSW-1425
Company DUNS080414615
Company NamePERSEON CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com
Phone801-972-5555
Emailsupport@perseonmedical.com

Device Dimensions

Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter
Length25 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100851551005156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEYSystem, Ablation, Microwave And Accessories

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


[00851551005156]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-09
Device Publish Date2017-08-19

On-Brand Devices [SynchroWave Antenna Kit]

0085155100515625cm Long Tip Antenna and Cooling Circuit
0085155100509520cm Short Tip Antenna and Cooling Circuit
0085155100508815cm Short Tip Antenna and Cooling Circuit
0085155100507120cm Long Tip Antenna and Cooling Circuit
0085155100506415cm Long Tip Antenna and Cooling Circuit

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