Model 2402 Maestro Mobile Charger

FDA UDI

Class III (US FDA UDI)

by ReShape Lifesciences Inc.

Identity

Trade Name: Model 2402 Maestro Mobile Charger FDA UDI
Generic Name: Implant battery charger/performance analyser FDA UDI
Device Name: The Model 2402 Mobile Charger (MC) is a non-sterile external component that is powered by a rechargeable, lithium-ion battery. The MC charges the Rechargeable Neuroregulator (RNR) when connected to a Transmit Coil positioned over the RNR. The MC also provides communication between the Clinician Programmer and RNR to allow up and down loading of data, display battery charge levels, indicate proper positioning of the Transmit Coil, alert patient to fault conditions, and allow for inactivation of therapy and turning off the RNR if needed. FDA UDI
Model / Reference: 2402 FDA UDI
Description: The Model 2402 Mobile Charger (MC) is a non-sterile external component that is powered by a rechargeable, lithium-ion battery. The MC charges the Rechargeable Neuroregulator (RNR) when connected to a Transmit Coil positioned over the RNR. The MC also provides communication between the Clinician Programmer and RNR to allow up and down loading of data, display battery charge levels, indicate proper positioning of the Transmit Coil, alert patient to fault conditions, and allow for inactivation of therapy and turning off the RNR if needed. FDA UDI

Identifiers

Catalog Number: 2402 FDA UDI
Primary DI / UDI-DI: 00857334004309 FDA UDI
PMA Number: P130019 FDA UDI
FDA Product Code: PIM FDA UDI
GMDN Term: Implant battery charger/performance analyser FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Width — 4.7 Inch FDA UDI
Height — 1.2 Inch FDA UDI
Length — 2 Inch FDA UDI

Model 2402 Maestro Mobile Charger by ReShape Lifesciences Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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: ReShape Lifesciences Inc.

Sources (1)

FDA UDI d575342c-8fe1-4970-9f8d-c2cc6e7233ab 39 fields · synced May 30, 2026