Model 2403-300 Maestro Clinician Transmit Coil

FDA UDI

Class III (US FDA UDI)

by ReShape Lifesciences Inc.

Identity

Trade Name: Model 2403-300 Maestro Clinician Transmit Coil FDA UDI
Generic Name: Vagus nerve electrical stimulation system programmer FDA UDI
Device Name: The Model 2403-300 Transmit Coil is a non-sterile external component that is placed within a standard sterile sleeve for use by a clinician in the operating room. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication. FDA UDI
Model / Reference: 2403-300 FDA UDI
Description: The Model 2403-300 Transmit Coil is a non-sterile external component that is placed within a standard sterile sleeve for use by a clinician in the operating room. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication. FDA UDI

Identifiers

Catalog Number: 2403-300 FDA UDI
Primary DI / UDI-DI: 00857334004316 FDA UDI
PMA Number: P130019 FDA UDI
FDA Product Code: PIM FDA UDI
GMDN Term: Vagus nerve electrical stimulation system programmer 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: Outer Diameter — 5 Inch FDA UDI

Model 2403-300 Maestro Clinician Transmit Coil 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 c2cb340e-92a4-40d7-b416-ad4e8335b066 39 fields · synced May 31, 2026