GUDID 00763000760649

STYLET 6057-65 STRGHT BALL MDR

MEDTRONIC, INC.

Pacing/defibrillation lead stylet
Primary Device ID00763000760649
NIH Device Record Key7dfe2e15-8628-4c3d-bda1-650cb17c5f24
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6057-65
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

Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter
Length65 Centimeter
Outer Diameter0.014 Inch
Outer Diameter0.356 Millimeter

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
GS100763000760649 [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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00199150001910 - IN.PACT™ 0182026-03-27 DCB 018XL IPU05025020P D5.0 L250 UL0200
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