Model 2002 Maestro Rechargeable Neuroregulator

FDA UDI

Class III (US FDA UDI)

by ReShape Lifesciences Inc.

Identity

Trade Name: Model 2002 Maestro Rechargeable Neuroregulator FDA UDI
Generic Name: Gastric contractility modulation system pulse generator FDA UDI
Device Name: The Model 2002 Rechargeable Neuroregulator (RNR) is provided sterile for implantation and has a hermetic case enclosure with an integrated coil that acts as an antenna for telemetry and recharging. The RNR is surgically implanted to deliver electrical current to the implanted leads. It contains a rechargeable battery which is charged transcutaneously using a Transmit Coil. FDA UDI
Model / Reference: 2002 FDA UDI
Description: The Model 2002 Rechargeable Neuroregulator (RNR) is provided sterile for implantation and has a hermetic case enclosure with an integrated coil that acts as an antenna for telemetry and recharging. The RNR is surgically implanted to deliver electrical current to the implanted leads. It contains a rechargeable battery which is charged transcutaneously using a Transmit Coil. FDA UDI

Identifiers

Catalog Number: 2002 FDA UDI
Primary DI / UDI-DI: 00857334004262 FDA UDI
PMA Number: P130019 FDA UDI
FDA Product Code: PIM FDA UDI
GMDN Term: Gastric contractility modulation system pulse generator FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Width — 86 Millimeter FDA UDI
Height — 16 Millimeter FDA UDI
Length — 71 Millimeter FDA UDI

Model 2002 Maestro Rechargeable Neuroregulator 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: ReShape Lifesciences Inc.

Sources (1)

FDA UDI e8b659cd-a553-4204-8ae6-c5f161779c3c 39 fields · synced May 30, 2026