GUDID 00613994100979

Extension, 3095-51,InterStim, US, 51cm

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor Neural-tissue electrical stimulation lead adaptor

Primary Device ID	00613994100979
NIH Device Record Key	b0b87548-bd61-4229-a2fd-08c72289a9a5
Commercial Distribution Status	In Commercial Distribution
Version Model Number	3095-51
Company DUNS	796986144
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	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

Device Dimensions

Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter
Length	51 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994100979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970004

FDA Product Code

EZW	Stimulator, electrical, implantable, for incontinence

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	2014-09-23

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