AOS Marker Seeds

FDA UDI

Class II (US FDA UDI)

by Alpha-Omega Services, Inc.

Identity

Trade Name: AOS Marker Seeds FDA UDI
Generic Name: Radiological image marker, implantable FDA UDI
Model / Reference: SMG0242-025 FDA UDI

Identifiers

Primary DI / UDI-DI: 00850645007007 FDA UDI
510(k) Number: K233626 FDA UDI
FDA Product Code: KXK FDA UDI
JAQ FDA UDI
GMDN Term: Radiological image marker, implantable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.5730 FDA UDI
892.5700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Radiological image marker, implantable

AOS Marker Seeds by Alpha-Omega Services, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Alpha-Omega Services, Inc.

Sources (1)

FDA UDI ed5f5a7d-d504-4d25-95ee-2d243e499bd1 33 fields · synced Jun 8, 2026