STYLET 6093-100 STRT EXTD TPR GLBL EIFU Medical Device Identification

GUDID 00763000059132

STYLET 6093-100 STRT EXTD TPR GLBL EIFU

MEDTRONIC, INC.

Pacing/defibrillation lead stylet

Primary Device ID	00763000059132
NIH Device Record Key	c06e8f87-32d2-4b2c-b674-7c5a6ff724d6
Commercial Distribution Status	In Commercial Distribution
Version Model Number	6093-100
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Outer Diameter	0.016 Inch
Outer Diameter	0.016 Inch
Outer Diameter	0.016 Inch
Outer Diameter	0.016 Inch
Outer Diameter	0.016 Inch
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch
Outer Diameter	0.406 Millimeter
Length	100 Centimeter
Outer Diameter	0.016 Inch

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000059132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P850089

FDA Product Code

DRB	STYLET, CATHETER

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-09-19
Device Publish Date	2018-08-19

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