Identity
- Trade Name
- Model 2403-60 Maestro Patient Transmit Coil FDA UDI
- Generic Name
- Vagus nerve electrical stimulation system programmer FDA UDI
- Device Name
- The Model 2403-60 Transmit Coil is a non-sterile external component for use by the patient. 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
- 2403-60 FDA UDI
- Description
- The Model 2403-60 Transmit Coil is a non-sterile external component for use by the patient. 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
- 2403-60 FDA UDI
- Primary DI / UDI-DI
- 00857334004323 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5 Inch FDA UDI
Model 2403-60 Maestro Patient 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 113a552f-fe36-4476-9b5e-98f00023380e 39 fields · synced Jun 6, 2026