Axonics

FDA UDI

Class III (US FDA UDI)

by Axonics Modulation Technologies, Inc.

Identity

Trade Name: Axonics FDA UDI
Generic Name: Medical ruler, single-use FDA UDI
Device Name: Axonics Foramen Finder FDA UDI
Model / Reference: FFG-01 FDA UDI
Description: Axonics Foramen Finder FDA UDI

Identifiers

Catalog Number: FFG-01 FDA UDI
Primary DI / UDI-DI: 10810005340523 FDA UDI
PMA Number: P180046 FDA UDI
P190006 FDA UDI
FDA Product Code: EZW FDA UDI
QON FDA UDI
GMDN Term: Medical ruler, single-use 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical ruler, single-use

Axonics by Axonics Modulation Technologies, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

P190006 also covers:

Axonics — AXONICS MODULATION TECHNOLOGIES, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Axonics Modulation Technologies, Inc.

Sources (1)

FDA UDI 2430a5ac-dc4d-4b52-a6a5-2f271488e80d 35 fields · synced Jun 6, 2026