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Secure Strand with Advantage I-125 in Strand Delivery System

FDA UDI

Class II (US FDA UDI)

by Isoaid, L.l.c.

Identity

Trade Name
Secure Strand with Advantage I-125 in Strand Delivery System FDA UDI
Generic Name
Prostate brachytherapy system applicator, manual FDA UDI
Device Name
Secure Strand with Advantage I-125 in Strand Delivery System FDA UDI
Model / Reference
ISDS FDA UDI
Description
Secure Strand with Advantage I-125 in Strand Delivery System FDA UDI

Identifiers

Primary DI / UDI-DI
M936ISDS9 FDA UDI
510(k) Number
K113210 FDA UDI
FDA Product Code
KXK FDA UDI
GMDN Term
Prostate 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
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Prostate brachytherapy system applicator, manual

Secure Strand with Advantage I-125 in Strand Delivery System by Isoaid, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Prostate brachytherapy system applicator, manual.

Cleared under the same submission

K113210 also covers:

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 3abd0baa-8a71-450d-956d-25ae0b9ceabc 34 fields · synced May 30, 2026