GUDID 00763000760663

STYLET 6057-110 STRGHT BALL MDR

MEDTRONIC, INC.

Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet Pacing/defibrillation lead stylet
Primary Device ID00763000760663
NIH Device Record Keyb0d1fae3-cc4b-4117-bd6a-cbb80fdbc152
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6057-110
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch
Length110 Centimeter
Outer Diameter0.356 Millimeter
Outer Diameter0.014 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000760663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRBSTYLET, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-13
Device Publish Date2024-05-05

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