Sonicicsion

GUDID 10884521781627

Reusable Battery Pack

Covidien LP

Soft-tissue ultrasonic surgical system
Primary Device ID10884521781627
NIH Device Record Key47ce6eb0-346b-4e3c-9ff7-5b0924b8421f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonicicsion
Version Model NumberSCBA
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
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
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
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

Operating and Storage Conditions

Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -22 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521781627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFLInstrument, ultrasonic surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-27
Device Publish Date2021-12-18

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30884522020279 - DAR2025-03-18 Catheter Mount
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20884521066172 - DAR2025-03-17 Catheter Mount Extendable
10884521528086 - DAR2025-03-17 Catheter Mount
20884522020081 - DAR2025-03-17 Catheter Mount

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