PlasmaBlade™

GUDID 00643169937963

PLASMABLADE PS300-004 SUCT COAG BLA 16PK

MEDTRONIC NAVIGATION, INC.

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Primary Device ID00643169937963
NIH Device Record Keyf9344bcf-e968-4765-9c82-ea51f9225c3b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlasmaBlade™
Version Model NumberPS300-004
Company DUNS835233107
Company NameMEDTRONIC NAVIGATION, INC.
Device Count16
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169937963 [Unit of Use]
GS120643169937967 [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 Date2020-05-26
Device Publish Date2020-05-18

On-Brand Devices [PlasmaBlade™]

00643169937963PLASMABLADE PS300-004 SUCT COAG BLA 16PK
00643169937970PLASMABLADE PS300-006 PEAK UPPP ENT
00643169937956PLASMABLADE PS300-003 ADENOID TIP RD
00643169937949PLASMABLADE PS300-002 TNA TIP RD
00643169937932PLASMABLADE PS300-001 TONSIL
00643169936713PLASMABLADE PS200-001 NEEDLE
00643169936706PLASMABLADE PS210-030S-SP LOCK
00643169936676PLASMABLADE PS210-030S 3.0S LOCK
00643169936669PLASMABLADE PS210-030P PLUS LOCK
00643169936652PLASMABLADE PS200-040-SP 4.0
00643169936621PLASMABLADE PS200-040 4.0

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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