Secure Strand® with Advantage Pd-103®

FDA UDI

Class II (US FDA UDI)

by Isoaid, L.l.c.

Identity

Trade Name: Secure Strand® with Advantage Pd-103® FDA UDI
Generic Name: Brachytherapy injection needle FDA UDI
Device Name: Secure Strand® with Advantage Pd-103® radioactive seeds FDA UDI
Model / Reference: PBKS FDA UDI
Description: Secure Strand® with Advantage Pd-103® radioactive seeds FDA UDI

Identifiers

Primary DI / UDI-DI: M936PBKSS9 FDA UDI
510(k) Number: K113210 FDA UDI
FDA Product Code: KXK FDA UDI
GMDN Term: Brachytherapy injection needle 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

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Brachytherapy injection needle

Secure Strand® with Advantage Pd-103® by Isoaid, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Brachytherapy injection needle.

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Stellar Medical — Stellar Medical, LLC · Class II
Best Medical International — Best Medical International, Inc. · Class II
Best Medical International — Best Medical International, Inc. · Class II

Cleared under the same submission

K113210 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 58a78b60-91b5-4398-8be0-73359915b622 34 fields · synced May 30, 2026