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Axonics

FDA UDI

Class III (US FDA UDI)

by Axonics Modulation Technologies, Inc.

Identity

Trade Name
Axonics FDA UDI
Generic Name
Sacral plexus implantable incontinence-control electrical stimulation system FDA UDI
Device Name
Neurostimulator FDA UDI
Model / Reference
4101 FDA UDI
Description
Neurostimulator FDA UDI

Identifiers

Catalog Number
4101 FDA UDI
Primary DI / UDI-DI
10810005340455 FDA UDI
FDA Product Code
EZW FDA UDI
QON 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Sacral plexus implantable incontinence-control electrical stimulation system

Axonics by Axonics Modulation Technologies, 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Axonics Modulation Technologies, Inc.

Sources (1)

  • FDA UDI b5909edd-69c0-4a0f-8792-9857bc10a659 35 fields · synced May 31, 2026