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Sign in to claim this brandMyriad Medical, LLC
US
Last updated May 27, 2026
What Myriad Medical, LLC makes
Myriad Medical, LLC manufactures single-use rectal probes and catheter/overtube balloon inflators, including luer lock syringes and immobilization rectal balloons designed for prostate procedures. Their products include the Prostate Caddy Rectal Balloon and related accessories for medical imaging and treatment applications.
The company’s devices are classified as Class I and Class II under FDA regulations, with some listed in the 510(k) and UDI registries. Their products are based in 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 Myriad Medical, LLC manufacture?
Myriad Medical, LLC specializes in single-use medical devices primarily for prostate procedures. Their products include rectal probes and catheter/overtube balloon inflators, such as luer lock syringes and immobilization rectal balloons. Examples include the Prostate Caddy Rectal Balloon and related accessories, which are designed to assist in medical imaging and treatment applications.
Where is Myriad Medical, LLC based?
Myriad Medical, LLC is based in the United States. The company’s headquarters and operations are located within the country, though specific locations are not provided.
Which regulatory registries list Myriad Medical, LLC’s devices?
Myriad Medical, LLC’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries help track and identify medical devices that have undergone the necessary regulatory processes, though listing alone does not imply authorization or clearance.
How are Myriad Medical, LLC’s devices classified under FDA regulations?
Myriad Medical, LLC’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose the lowest risk and may be exempt from some premarket submissions, while Class II devices require special controls to ensure safety and effectiveness. The classification depends on the specific device and its intended use.
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
- 842448610
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Inflation Luer Lock Syringe | 100 | FDA UDI | Class I | Active |
| Prostate Caddy Rectal Balloon | 3301 | FDA UDI | Class II | Active |
| Prostate Caddy Rectal Balloon | 9901 | FDA UDI | Class II | Active |
| Prostate Caddy Rectal Balloon | 3309 | FDA UDI | Class II | Active |
| Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901, 3301 | K150234 | FDA 510(k) | Class II | Active |
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