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Advantage Pd-103®

FDA UDI

Class II (US FDA UDI)

by Isoaid, L.l.c.

Identity

Trade Name
Advantage Pd-103® FDA UDI
Generic Name
Eye brachytherapy system applicator, manual FDA UDI
Device Name
Advantage Pd-103 radioactive seeds with a molded form that is shielded on one side containing grooved positions for manual brachytherapy sources on the other side used for the temporary topical application of brachytherapy sources to the surface of the eye; sterile. FDA UDI
Model / Reference
PEPS FDA UDI
Description
Advantage Pd-103 radioactive seeds with a molded form that is shielded on one side containing grooved positions for manual brachytherapy sources on the other side used for the temporary topical application of brachytherapy sources to the surface of the eye; sterile. FDA UDI

Identifiers

Primary DI / UDI-DI
M936PEPS9 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

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Manual brachytherapy source, permanent implantEye brachytherapy system applicator, manual

Advantage Pd-103® 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Isoaid, L.l.c.

Sources (1)

  • FDA UDI 2875fd3d-9b04-491f-bcd0-3391563b02b2 33 fields · synced May 30, 2026