Cor-Valv Atrial Retractor Cables with Fitting 1011180

GUDID 10817121000195

The Cor-Valv Cable is intended to be used with the corresponding CORONEO Cor-Valv system retractor for retraction of heart tissue during cardiac surgery. This product is provided sterile in a sealed package, and consists one(1) cable that is single-use and disposable held by a plastic insert.

Coroneo Inc

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Primary Device ID10817121000195
NIH Device Record Key28ece483-476d-4dfb-994a-550ed06bb06c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCor-Valv Atrial Retractor Cables with Fitting
Version Model Number1011180
Catalog Number1011180
Company DUNS255276362
Company NameCoroneo Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com
Phone+1(514)336-9230
Emailinfo@coroneo.com

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817121000198 [Primary]
GS110817121000195 [Package]
Contains: 00817121000198
Package: Box [10 Units]
In Commercial Distribution

FDA Product Code

GADRetractor

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-06
Device Publish Date2022-09-28

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