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: Eye brachytherapy system applicator, manual FDA UDI
Device Name: Advantage I-125® radioactive seeds with a molded form that is shielded on one side and contains grooved positions for manual brachytherapy sources on the other side and is used for the temporary topical application of brachytherapy sources to the surface of the eye. FDA UDI
Model / Reference: IEPS FDA UDI
Description: Advantage I-125® radioactive seeds with a molded form that is shielded on one side and contains grooved positions for manual brachytherapy sources on the other side and is used for the temporary topical application of brachytherapy sources to the surface of the eye. FDA UDI

Identifiers

Primary DI / UDI-DI: M936IEPS9 FDA UDI
FDA Product Code: KXK FDA UDI
GMDN Term: Eye brachytherapy system applicator, manual 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 Conditional FDA UDI

Category: Eye brachytherapy system applicator, manual

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 Eye brachytherapy system applicator, manual.

Advantage Pd-103® — ISOAID, L.L.C. · Class II

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 e2217c2c-8d14-4c29-a8fc-f96954727b57 33 fields · synced May 30, 2026