Attain Performa™ S MRI SureScan™

GUDID 00643169601871

LEAD 459888 MRI S-TIP US

MEDTRONIC, INC.

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Primary Device ID	00643169601871
NIH Device Record Key	0e044365-9cae-42be-82e0-760b9b2332f6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Attain Performa™ S MRI SureScan™
Version Model Number	459888
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	true
Single Use	true
Lot Batch	false
Serial Number	true
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
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

Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter
Length	88 Centimeter

Operating and Storage Conditions

Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169601871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P080006

FDA Product Code

DTB	permanent pacemaker Electrode

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-02-26

On-Brand Devices [Attain Performa™ S MRI SureScan™]

00643169601871	LEAD 459888 MRI S-TIP US
00643169601864	LEAD 459878 MRI S-TIP US