PlasmaBlade™ X

GUDID 00763000059842

PLASMABLADE X PS200-040 4.0 GREEN

MEDTRONIC NAVIGATION, INC.

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID00763000059842
NIH Device Record Key4cf60862-2356-4b39-8890-c268a25dab57
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlasmaBlade™ X
Version Model NumberPS200-040
Company DUNS835233107
Company NameMEDTRONIC NAVIGATION, 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

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 32 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000059842 [Primary]

FDA Product Code

GEIElectrosurgical, cutting & coagulation & accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-03
Device Publish Date2020-06-25

On-Brand Devices [PlasmaBlade™ X]

00763000279189PLASMABLADEX PS210-030S-LIGHT 3.0SL PINK
00763000279172PLASMABLADE X PS210-030S-LIGHT 3.0SL
00763000279165PLASMABLADE X PS210-030S-LIGHT 3.0SL
00763000279141PLASMABLADE X PS200-041S 4.0S GREEN
00763000059880PLASMABLADE X PS200-041S 4.0S PINK
00763000059842PLASMABLADE X PS200-040 4.0 GREEN
00763000059811PLASMABLADE X PS210-030S 3.0S GREEN
00643169936683PLASMABLADE X PS210-030S PINK
00643169936638PLASMABLADE X PS200-040 4.0 PINK
00763000059873PLASMABLADE X PS200-041S 4.0S

Trademark Results [PlasmaBlade]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PLASMABLADE
PLASMABLADE
86271763 4652853 Live/Registered
Medtronic Advanced Energy LLC
2014-05-05

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