Emprint HP

GUDID 10884521850033

Ablation Generator with Thermosphere Technology 150W;Caution: For manufacturing, processing, or repacking.

Covidien LP

Microwave hyperthermia system
Primary Device ID10884521850033
NIH Device Record Key2e1a04d7-f7de-4ff6-bd49-1c1df24b453a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmprint HP
Version Model NumberCAGENHP
Company DUNS058614483
Company NameCovidien LP
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

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Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 66 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521850033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEYSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-12
Device Publish Date2025-03-04

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