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Otomag™ Alpha (M) Magnetic Implant

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name
Otomag™ Alpha (M) Magnetic Implant FDA UDI
Generic Name
Head-worn bone-conduction hearing aid implantable magnet FDA UDI
Device Name
MAGNETIC IMPLANT S0263-01 MRI COND FDA UDI
Model / Reference
S0263-01 FDA UDI
Description
MAGNETIC IMPLANT S0263-01 MRI COND FDA UDI

Identifiers

Primary DI / UDI-DI
00643169645318 FDA UDI
510(k) Number
K123962 FDA UDI
FDA Product Code
LXB FDA UDI
GMDN Term
Head-worn bone-conduction hearing aid implantable magnet FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3302 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Otomag™ Alpha (M) Magnetic Implant by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI 5681162f-a00a-4ace-8e81-e0ac61eca24a 37 fields · synced May 31, 2026