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 source, permanent implant FDA UDI
Device Name: Radioactive I-125 seeds, loose, in vial FDA UDI
Model / Reference: ILVS FDA UDI
Description: Radioactive I-125 seeds, loose, in vial FDA UDI

Identifiers

Primary DI / UDI-DI: M936ILVS9 FDA UDI
510(k) Number: K011205 FDA UDI
FDA Product Code: KXK FDA UDI
GMDN Term: Manual brachytherapy source, permanent implant 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Manual brachytherapy source, permanent implant

Advantage I-125 device is a manually implanted radioactive source used for permanent brachytherapy, providing targeted and effective treatment of various medical conditions. It consists of sterilized radioactive seeds in vial format, suitable for safe use in clinics and hospitals worldwide.

Similar devices

Also classified as Manual brachytherapy source, permanent implant.

OncoSeedTM — MEDI-PHYSICS, INC. · Class II
TheraSeed — THERAGENICS CORP. · Class II
TheraSeed® — BARD BRACHYTHERAPY, INC · Class II
I-125 SeedTM Sterile Convenience Pack — MEDI-PHYSICS, INC. · Class II
TheraSphere Y90 Glass Microspheres 16.0 GBq (US Commercial) — BIOCOMPATIBLES UK LTD · Class III
Gold Marker — RIVERPOINT MEDICAL LLC · Class II
Thin SeedTM — MEDI-PHYSICS, INC. · Class II
OncoSeedTM — MEDI-PHYSICS, INC. · Class II

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 1c251e71-7248-465f-a991-dc0dd923fe48 34 fields · synced Jul 19, 2026