Identity
- Trade Name
- Magnet FDA UDI
- Generic Name
- Active implantable device control magnet FDA UDI
- Device Name
- The Magnet package contains 1 Magnet. FDA UDI
- Model / Reference
- M-01 FDA UDI
- Description
- The Magnet package contains 1 Magnet. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855547005137 FDA UDI
- PMA Number
- P100026 FDA UDI
- FDA Product Code
- PFN FDA UDI
- GMDN Term
- Active implantable device control magnet FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Active implantable device control magnet
Magnet by Neuropace, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Active implantable device control magnet.
- VITARIA™ Patient Essentials, Model 7220 — LivaNova USA, Inc. · Class I
- Senza — Nevro Corporation · Class III
- BIOTRONIK — BIOTRONIK SE & Co. KG · Class III
- ReActiv8 Magnet — MAINSTAY MEDICAL LIMITED · Class III
- Cyberonics® Patient Magnet — LivaNova USA, Inc. · Class I
- Algovita® — Greatbatch Ltd · Class III
- Axium™ — ST. JUDE MEDICAL, 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.
- 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.
- 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 015067b3-70ca-478c-be8e-633889b30a90 35 fields · synced May 30, 2026