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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 6886 Bateman Dell Way, West Jordan, UT, 84084
- 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
- 3015152450
- DUNS Number
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Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Intuitive Depth Bougie™ (IDB), Coude Tip | 000118 | FDA UDI | Class I | Active |
| Runnels Steerable Introducer™ #4 Oral | 001031 | FDA UDI | Class I | Active |
| Total Control Introducer™ (TCI) | 000163 | FDA UDI | Class I | Unknown |
| Runnels Steerable Introducer™ #5 Nasal | 001079 | FDA UDI | Class I | Active |
| Runnels Steerable Introducer™ #3 Oral/Nasal | 001085 | FDA UDI | Class I | Active |
| Runnels Steerable Introducer™ DLT (35F/37F) | 001109 | FDA UDI | Class I | Active |
| Runnels Steerable Introducer™ DLT (39F/41F) | 001103 | FDA UDI | Class I | Active |
| Intuitive Depth Exchange™ Catheter (IDE) | 000294 | FDA UDI | Class I | Active |
| Runnels Steerable Introducer™ #2.5 Oral/Nasal | 001091 | FDA UDI | Class I | Active |
| Runnels Steerable Introducer™ (rSI) | 001031 | FDA UDI | Class I | Active |
| Runnels Steerable Introducer™ #2 Oral/Nasal | 001097 | FDA UDI | Class I | Active |
| Runnels Steerable Introducer™ #4 Nasal | 001050 | FDA UDI | Class I | Active |
| TCI™ Si | 000946 | FDA UDI | Class I | Active |
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