Identity
- Trade Name
- Axium™ FDA UDI
- Generic Name
- Active implantable device control magnet FDA UDI
- Device Name
- Auxiliary Magnet FDA UDI
- Model / Reference
- MN23300 FDA UDI
- Description
- Auxiliary Magnet FDA UDI
Identifiers
- Catalog Number
- MN23300 FDA UDI
- Primary DI / UDI-DI
- 05415067025623 FDA UDI
- PMA Number
- P150004 FDA UDI
- FDA Product Code
- PMP 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Active implantable device control magnet
Axium™ by St. Jude Medical, 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
- Magnet — Neuropace, Inc. · Class III
- 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
Cleared under the same submission
P150004 also covers:
- NeuroSphere™ — Advanced Neuromodulation Systems
- Proclaim™ — Advanced Neuromodulation Systems
- SlimTip™ — Advanced Neuromodulation Systems
- SlimTip™ — Advanced Neuromodulation Systems
- SlimTip™ — Advanced Neuromodulation Systems
- SlimTip™ — Advanced Neuromodulation Systems
- Axium™ — SPINAL MODULATION, INC.
- Axium™ — SPINAL MODULATION, INC.
- Axium™ — SPINAL MODULATION, INC.
- Axium™ — SPINAL MODULATION, INC.
- Axium™ — SPINAL MODULATION, INC.
- Axium™ — SPINAL MODULATION, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 81ecff32-680f-4ae2-a60b-e989e77d535a 37 fields · synced Jun 8, 2026