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Sign in to claim this brandISOAID, L.L.C.
US
Last updated May 24, 2026
What ISOAID, L.L.C. makes
The company manufactures brachytherapy devices for targeted radiation therapy, including manual sources for temporary and permanent implants, injection needles, and applicators for eye and prostate procedures. Products include radioactive seed systems like I-125 and Pd-103, as well as single-use needle guides and complete manual brachytherapy systems designed for precision placement.
These devices are classified under FDA regulations as Class I and Class II, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable U.S. medical device compliance requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does ISOAID, L.L.C. manufacture?
ISOAID, L.L.C. specializes in brachytherapy devices, which deliver targeted radiation therapy for cancer treatment. Their products include manual brachytherapy sources for both temporary and permanent implants, brachytherapy injection needles, and applicators for eye and prostate procedures. Examples include radioactive seed systems like I-125 and Pd-103, as well as complete manual brachytherapy systems designed for precise radiation delivery.
Where is ISOAID, L.L.C. based, and what does that mean for their devices?
ISOAID, L.L.C. is based in the United States, meaning their devices are subject to U.S. medical device regulations. This includes compliance with FDA requirements for manufacturing, labeling, and post-market surveillance. The company’s location also influences which regulatory databases and registries their devices may appear in, such as the FDA’s Unique Device Identifier (UDI) database.
Which regulatory registries list ISOAID, L.L.C.’s devices?
ISOAID, L.L.C.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to verify device details such as manufacturer information, model names, and classification. The UDI system is a key resource for tracking medical devices authorized for use in the U.S.
How are ISOAID, L.L.C.’s devices classified under FDA regulations?
ISOAID, L.L.C.’s devices are classified under FDA regulations as either Class I or Class II. Class I devices generally pose the lowest risk and may be subject to general controls, while Class II devices require additional regulations to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, such as brachytherapy applicators or radioactive seed systems.
What does it mean for ISOAID, L.L.C.’s devices to be listed in the FDA’s UDI database?
Listing in the FDA’s UDI database means that each of ISOAID, L.L.C.’s devices has a unique identifier assigned to it, ensuring clear and standardized tracking. This helps prevent confusion between similar devices, supports supply chain transparency, and aids in post-market surveillance. The UDI also facilitates recalls, compliance checks, and regulatory reporting, which are critical for maintaining patient safety and device accountability.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 002751241
Catalogue (54)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Advantage I-125 | RSLN-15SS | FDA UDI | Class II | Active |
| Advantage-Load® with Advantage I-125® | IBKA | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-12 | FDA UDI | Class II | Active |
| Advantage Pd-103® | PLVN | FDA UDI | Class II | Active |
| Advantage-Strand® with Advantage Pd-103® | PBKA | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-12 | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-7 | FDA UDI | Class II | Active |
| Advantage I-125® | ILVN | FDA UDI | Class II | Active |
| Advantage I-125® | ILVS | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-20 | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-05 | FDA UDI | Class II | Active |
| Advantage-Strand® with Advantage I-125® | IBKA | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-7 | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-07 | FDA UDI | Class II | Active |
| Advantage Pd-103® | PMLN | FDA UDI | Class II | Active |
| Advantage Pd-103® | PEPS | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-5 | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-20 | FDA UDI | Class II | Active |
| Advantage Pd-103® | PLVS | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-12 | FDA UDI | Class II | Active |
| Secure Strand® with Advantage Pd-103® | PBKS | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-12 | FDA UDI | Class II | Active |
| Advantage I-125® | ILVN | FDA UDI | Class II | Active |
| Advantage Pd-103® | PLVS | FDA UDI | Class II | Active |
| Advantage Pd-103® | PLVN | FDA UDI | Class II | Active |
| Advantage I-125® | IEPS | FDA UDI | Class II | Active |
| Advantage I-125 | RSLN-15S | FDA UDI | Class II | Active |
| Advantage I-125 | RSLN-15SSS | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-20 | FDA UDI | Class II | Active |
| Guide Needle | BGNS | FDA UDI | Class I | Active |
| Advantage I-125® | RSLN-20 | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN | FDA UDI | Class II | Active |
| Secure Strand with Advantage I-125 in Strand Delivery System | ISDS | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-05 | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-12 | FDA UDI | Class II | Active |
| Advantage-Load® with Advantage Pd-103® | PBKA | FDA UDI | Class II | Active |
| Advantage I-125® | IMLS | FDA UDI | Class II | Active |
| Advantage-Strand® and Advantage-Load® with Advantage I-125® | IBKA | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-12 | FDA UDI | Class II | Active |
| Advantage-Strand® and Advantage-Load® and Advantage Pd-103® | PBKA | FDA UDI | Class II | Active |
| Secure Strand® and Advantage-Load® with Advantage Pd-103® | PBKS | FDA UDI | Class II | Active |
| Advantage I-125® | IBKS | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-20 | FDA UDI | Class II | Active |
| Secure Strand® with Advantage I-125® | IBKS | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-07 | FDA UDI | Class II | Active |
| Advantage Pd-103® | PMLS | FDA UDI | Class II | Active |
| Advantage I-125® | IMLN | FDA UDI | Class II | Active |
| Advantage I-125® | ILVS | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-5 | FDA UDI | Class II | Active |
| Advantage I-125® | RSLN-5 | FDA UDI | Class II | Active |
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