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Interstim®

FDA UDI

Class III (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name
INTERSTIM® FDA UDI
Generic Name
Sacral plexus implantable incontinence-control electrical stimulation system FDA UDI
Device Name
INS 3058 INTERSTIM II eMANUAL US FDA UDI
Model / Reference
3058 FDA UDI
Description
INS 3058 INTERSTIM II eMANUAL US FDA UDI

Identifiers

Primary DI / UDI-DI
00613994913654 FDA UDI
PMA Number
P080025 FDA UDI
P970004 FDA UDI
FDA Product Code
EZW FDA UDI
GMDN Term
Sacral plexus implantable incontinence-control electrical stimulation system FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
876.5270 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Sacral plexus implantable incontinence-control electrical stimulation system

Interstim® by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sacral plexus implantable incontinence-control electrical stimulation system.

Cleared under the same submission

P080025 also covers:

P970004 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic, Inc.

Sources (1)

  • FDA UDI 1b16fed5-a47f-47bb-aa6f-34abfc3f14e3 36 fields · synced May 30, 2026