Identity
- Trade Name
- Axium™ FDA UDI
- Generic Name
- Epidural needle, non-threaded FDA UDI
- Device Name
- Curved Needle FDA UDI
- Model / Reference
- MN14000 FDA UDI
- Description
- Curved Needle FDA UDI
Identifiers
- Catalog Number
- MN14000 FDA UDI
- Primary DI / UDI-DI
- 05415067025708 FDA UDI
- PMA Number
- P150004 FDA UDI
- FDA Product Code
- PMP FDA UDI
- GMDN Term
- Epidural needle, non-threaded 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 14 Gauge FDA UDILength — 4.5 Inch FDA UDI
Category: Epidural needle, non-threaded
Axium™ by Spinal Modulation, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Epidural needle, non-threaded.
- Entrada ™ — Boston Scientific Neuromodulation · Class III
- CODMAN® — Integra LifeSciences Production Corporation · Class I
- Tuohy Epidural Needle — REMINGTON MEDICAL, INC. · Class II
- Halyard — AVID MEDICAL, INC. · Class II
- TUOHY — Pajunk GmbH Medizintechnologie · Class II
- TuohySono — Pajunk GmbH Medizintechnologie · Class II
- Tuohy Epidural Needle — REMINGTON MEDICAL, INC. · Class II
- LCCS — Lccs Products Limited · Class II
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 |
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Manufacturer
- Manufacturer
- Spinal Modulation, Inc.
Sources (1)
- FDA UDI f1681c16-8467-43e1-8beb-a2ceb1cac926 38 fields · synced May 30, 2026