INTERSTIM® II

GUDID 00643169974760

INS 3058 INTERSTIM II EMAN US GRC

MEDTRONIC, INC.

Implantable incontinence-control electrical stimulation system pulse generator
Primary Device ID00643169974760
NIH Device Record Key837a5598-7ceb-406d-9721-9a8ef5ae2b1a
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTERSTIM® II
Version Model Number3058
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169974760 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-03
Device Publish Date2019-05-24

Devices Manufactured by MEDTRONIC, INC.

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00199150050161 - NA2025-09-29 CUSTOM PACK HLO BB12D44R4 PUMP PK
00199150050178 - NA2025-09-29 CUSTOM PACK BB4W67R26 EVL ADULT E

Trademark Results [INTERSTIM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTERSTIM
INTERSTIM
74469362 2072076 Live/Registered
Medtronic, Inc.
1993-12-13

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