GUDID 00613994100979

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

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead adaptor
Primary Device ID00613994100979
NIH Device Record Keyb0b87548-bd61-4229-a2fd-08c72289a9a5
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3095-51
Company DUNS796986144
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 Batchfalse
Serial Numbertrue
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
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

Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter
Length51 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994100979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EZWStimulator, electrical, implantable, for incontinence

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

00763000300623 - N/A2026-01-08 COMM HANDSET KIT TH90T01 TDD PROX MYPTM
00763000596958 - InterStim™ SureScan™2026-01-08 LEAD 978B133 ISTM SSMRI 4.32MM EMAN GLBL
00763000596996 - InterStim™ SureScan™2026-01-08 LEAD 978B141 ISTM SSMRI 4.32MM EMAN GLBL
00763000994198 - N/A2026-01-07 ACCY KIT 3550-68 TWIST LOCK SCRN CBL MDR
00199150065684 - NA2026-01-06 CUSTOM PACK BB11W65R6 HLO SPECTRUM
00199150065691 - NA2026-01-06 CUSTOM PACK BB6V93R18 EVL A 3/8 E
00199150065745 - NA2026-01-06 CUSTOM PACK BB10V37R6 EVL 1/4 PED
20199150065763 - NA2026-01-06 CUSTOM PACK BB11V27R2 10PK ACC 3/8 CONN

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.