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Axium™

FDA UDI

Class III (US FDA UDI)

by Spinal Modulation, Inc.

Identity

Trade Name
Axium™ FDA UDI
Generic Name
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection FDA UDI
Device Name
50cm SlimTip Trial Lead Kit FDA UDI
Model / Reference
MN10350-50A FDA UDI
Description
50cm SlimTip Trial Lead Kit FDA UDI

Identifiers

Catalog Number
MN10350-50A FDA UDI
Primary DI / UDI-DI
05415067025517 FDA UDI
PMA Number
P150004 FDA UDI
FDA Product Code
PMP FDA UDI
GMDN Term
Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection 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

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

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 50 Centimeter FDA UDI

Axium™ by Spinal Modulation, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P150004 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spinal Modulation, Inc.

Sources (1)

  • FDA UDI eb260244-25c2-4a38-8b1b-9f47e4ceb389 39 fields · synced Jun 1, 2026