Cutter Driver

GUDID 00763000918965

ATHERECTOMY FG02550 CUTTERDRIVER UNI

MEDTRONIC, INC.

Mechanical atherectomy system catheter, peripheral
Primary Device ID00763000918965
NIH Device Record Key21901806-30ce-4007-a9d5-72208aab85ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameCutter Driver
Version Model NumberFG02550
Company DUNS006261481
Company NameMEDTRONIC, INC.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to organic solvents, ionizing radiation, ultraviolet light or alcohol-based fluids.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -29 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000918965 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCWCatheter, peripheral, atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-19
Device Publish Date2024-08-10

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