Identity
- Trade Name
- RNS® Neurostimulator Kit FDA UDI
- Generic Name
- Brain-responsive electrical stimulation system FDA UDI
- Device Name
- The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver. FDA UDI
- Model / Reference
- RNS-320-K FDA UDI
- Description
- The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855547005366 FDA UDI
- PMA Number
- P100026 FDA UDI
- FDA Product Code
- PFN FDA UDI
- GMDN Term
- Brain-responsive electrical stimulation system FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Brain-responsive electrical stimulation system
RNS® Neurostimulator Kit by Neuropace, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Brain-responsive electrical stimulation system.
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- NeuroPace® Programmer Kit — Neuropace, Inc. · Class III
- Wand — Neuropace, Inc. · Class III
- NeuroPace® Remote Monitor Kit — Neuropace, Inc. · Class III
- Ferrule Kit — Neuropace, Inc. · Class III
- NeuroPace® Depth Lead Kit — Neuropace, Inc. · Class III
Cleared under the same submission
P100026 also covers:
- Connector Cover Kit — Neuropace, Inc.
- Connector Cover Kit — Neuropace, Inc.
- Craniectomy Template Kit — Neuropace, Inc.
- Craniectomy Template Kit — Neuropace, Inc.
- Explant Kit — Neuropace, Inc.
- Ferrule Kit — Neuropace, Inc.
- Ferrule Kit — Neuropace, Inc.
- Magnet — Neuropace, Inc.
- NeuroPace® Cortical Strip Lead Kit — Neuropace, Inc.
- NeuroPace® Cortical Strip Lead Kit — Neuropace, Inc.
- NeuroPace® Cortical Strip Lead Kit — Neuropace, Inc.
- NeuroPace® Cortical Strip Lead Kit — Neuropace, Inc.
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
- Neuropace, Inc.
Sources (1)
- FDA UDI 2be878f4-5586-49e3-836b-4475a11910de 36 fields · synced May 30, 2026