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US
Last updated May 24, 2026
What MEDI-PHYSICS, INC. makes
The company manufactures permanent implant brachytherapy sources designed for internal radiation therapy, including iodine-125 seeds and preloaded carrier systems for prostate and other solid tumor treatments. Products include single-strand implants like the RAPID STRAND and seed-based implants such as OncoSeed and Thin Seed variants, as well as sterile convenience packs for procedural efficiency.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) pathway and the Unique Device Identifier (UDI) system. The manufacturer’s products are listed in the FDA’s regulatory databases, and the company operates from the United States.
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 MEDI-PHYSICS, INC. manufacture?
MEDI-PHYSICS, INC. specializes in permanent implant brachytherapy sources, which are used for internal radiation therapy. Their devices include iodine-125 (I-125) seeds and preloaded carrier systems designed for treating prostate and other solid tumors. Examples include single-strand implants like the RAPID STRAND™ and seed-based implants such as OncoSeed™ and Thin Seed™ variants, as well as sterile convenience packs for procedural efficiency.
Where is MEDI-PHYSICS, INC. based, and what does that mean for its regulatory oversight?
MEDI-PHYSICS, INC. is based in the United States, meaning its devices fall under FDA regulatory jurisdiction. Since the company’s products are Class II devices, they are subject to the FDA’s 510(k) premarket notification process and must comply with the Unique Device Identifier (UDI) system for traceability and tracking.
Which regulatory registries or databases list MEDI-PHYSICS, INC.’s devices?
MEDI-PHYSICS, INC.’s devices are listed in the FDA’s 510(k) database (for premarket clearance) and the FDA’s Unique Device Identifier (UDI) system, which ensures standardized identification and tracking of medical devices in the U.S. These registries help healthcare providers and regulators verify the authorised status of their products.
How are MEDI-PHYSICS, INC.’s devices classified under FDA regulations, and why does that matter?
MEDI-PHYSICS, INC.’s devices are classified as Class II under FDA regulations, indicating they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification means they must undergo 510(k) clearance—a premarket submission process—to demonstrate that the device is substantially equivalent to a legally marketed predicate device, ensuring compliance with regulatory standards before patient use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- +1(800)228-0126
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 059470927
Catalogue (161)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OncoSeedTM | 6711 - Iodine I-125 Seed 55.5 mCi | FDA UDI | Class II | Active |
| Thin SeedTM | 9011 - I-125 Seed 0.863 mCi | FDA UDI | Class II | Active |
| OncoSeedTM | 6711 - Iodine I-125 Seed 1.298 mCi | FDA UDI | Class II | Active |
| Rapid Strandtm | 7000 - I-125 Seed 0.324 mCi | FDA UDI | Class II | Active |
| Thin SeedTM | 9011 - I-125 Seed 0.676 mCi | FDA UDI | Class II | Active |
| RAPID StrandTM Rx | 6716 RSRx Sleeve Square Needle | FDA UDI | Class II | Active |
| OncoSeedTM | 6711 - Iodine I-125 Seed 13.86 mCi | FDA UDI | Class II | Active |
| Thin SeedTM | 9011 - I-125 Seed 0.623 mCi | FDA UDI | Class II | Active |
| Thin SeedTM | 9011 - I-125 Seed 0.275 mCi | FDA UDI | Class II | Active |
| I-125 SeedTM Sterile Convenience Pack | 6715 - I-125 Seed 0.275mCi | FDA UDI | Class II | Active |
| Rapid Strand Rx | K122764 | FDA 510(k) | Class II | Active |
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