Identity
- Trade Name
- Model 2004 Maestro Implant Kit FDA UDI
- Generic Name
- Gastric contractility modulation system FDA UDI
- Device Name
- The Model 2004 Implant Kit consists of a Model 2002 Rechargeable Neuroregulator (including Model 1680 Torque Wrench), a Model 2200P-47E Maestro Posterior Lead, and a Model 2200A-47E Anterior Lead packaged together. FDA UDI
- Model / Reference
- 2004 FDA UDI
- Description
- The Model 2004 Implant Kit consists of a Model 2002 Rechargeable Neuroregulator (including Model 1680 Torque Wrench), a Model 2200P-47E Maestro Posterior Lead, and a Model 2200A-47E Anterior Lead packaged together. FDA UDI
Identifiers
- Catalog Number
- 2004 FDA UDI
- Primary DI / UDI-DI
- 00857334004279 FDA UDI
- PMA Number
- P130019 FDA UDI
- FDA Product Code
- PIM FDA UDI
- GMDN Term
- Gastric contractility modulation system 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Model 2004 Maestro Implant Kit 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 400d27b0-6ca3-4a98-a54f-6d5769a6f9a3 38 fields · synced May 30, 2026