Advantage I-125®

FDA UDI

Class II (US FDA UDI)

by Isoaid, L.l.c.

Identity

Trade Name: Advantage I-125® FDA UDI
Generic Name: Manual brachytherapy system FDA UDI
Device Name: Advantage I-125® radioactive seeds, Magazine/Cartridge Load, Sterile FDA UDI
Model / Reference: IMLS FDA UDI
Description: Advantage I-125® radioactive seeds, Magazine/Cartridge Load, Sterile FDA UDI

Identifiers

Primary DI / UDI-DI: M936IMLS9 FDA UDI
510(k) Number: K011205 FDA UDI
FDA Product Code: KXK FDA UDI
GMDN Term: Manual brachytherapy system FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Manual brachytherapy system

Advantage I-125® by Isoaid, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual brachytherapy system.

I-125 Seed — Eckert & Ziegler BEBIG GmbH · Class II
EchoStrand Brachytherapy Kit I-125 — Eckert & Ziegler BEBIG GmbH
Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, 3pk — Eckert & Ziegler BEBIG GmbH · Class I
Applicator Brachytherapy Kit — Eckert & Ziegler BEBIG GmbH
CivaDerm — CivaTech Oncology Inc. · Class II
AnchorLoad Brachytherapy Kit — Eckert & Ziegler BEBIG GmbH
VariLoad Brachytherapy Kit PD-103 — Eckert & Ziegler BEBIG GmbH
AnchorLoad Brachytherapy Kit - Loose Load — Eckert & Ziegler BEBIG GmbH

Cleared under the same submission

K011205 also covers:

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: Isoaid, L.l.c.

Sources (1)

FDA UDI fec240a6-ae3b-4517-8cdd-f6d430440267 34 fields · synced May 30, 2026