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Sign in to claim this brandWhat ClaroNav Kolahi Inc makes
ClaroNav Kolahi Inc manufactures stereotactic surgical systems for neurological and ENT (ear, nose, and throat) procedures, including tools like the Frontal Seeker, Tip Calibrator, and articulated arm for precise navigation. Their portfolio includes accessories such as clamps, probes, and registration tools designed to assist in targeted surgical planning and execution. The company also provides specialized kits, like the NaviENT Accessory Kit-B and Maxillary Seeker B, tailored for specific anatomical regions.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in the United States, adhering to applicable medical device standards and 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 ClaroNav Kolahi Inc manufacture?
ClaroNav Kolahi Inc specializes in stereotactic surgical systems, which are precision tools used in targeted surgeries. Their devices include neurological stereotactic systems, such as the Frontal Seeker and Articulated Arm, as well as ENT (ear, nose, and throat) stereotactic systems like the Maxillary Seeker B and NaviENT Accessory Kits. These tools assist surgeons in planning and executing minimally invasive procedures with high accuracy.
Where is ClaroNav Kolahi Inc based, and where are their devices primarily used?
ClaroNav Kolahi Inc is based in the United States. Their devices are designed and intended for use within the U.S. regulatory framework, adhering to applicable medical device standards and requirements. The company’s focus on stereotactic systems ensures their products align with surgical needs in the American healthcare system.
Which regulatory registries list ClaroNav Kolahi Inc’s devices?
ClaroNav Kolahi Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency and traceability of medical devices under FDA oversight, allowing healthcare providers and regulators to verify product details and compliance information.
How are ClaroNav Kolahi Inc’s devices classified under FDA regulations?
ClaroNav Kolahi Inc’s devices fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. Class II devices undergo rigorous review to balance regulatory oversight with innovation in surgical precision tools.
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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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 203466065
Catalogue (39)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Frontal Seeker | 950-NE-FS | EUDAMEDFDA UDI | Class II | Active |
| Tip Calibrator | 950-NE-TP | FDA UDI | Class II | Active |
| Frontal Seeker B | 950-NE-FS-B | EUDAMEDFDA UDI | Class II | Active |
| NaviENT Accessory Kit-B | 955-NE-ACCK-B | EUDAMEDFDA UDI | Class II | Active |
| C-Clamp XL | 950-NE-UTCXL | FDA UDI | Class II | Active |
| Navient Accessory kit - cranial | 955-NC-AKC | FDA UDI | Class II | Active |
| Tip Calibrator B | 950-NE-TC-B | EUDAMEDFDA UDI | Class II | Active |
| Articulated Arm | 950-NC-CAA | EUDAMEDFDA UDI | Class II | Active |
| Maxillary Seeker B | 950-NE-MS-B | EUDAMEDFDA UDI | Class II | Active |
| C-Clamp Large | 950-NE-UTCL | EUDAMEDFDA UDI | Class II | Active |
| Straight probe | 950-NC-SP | FDA UDI | Class II | Active |
| Registration probe B | 950-NE-RP-B | FDA UDI | Class II | Active |
| Registration Probe | 950-NE-RP | EUDAMEDFDA UDI | Class II | Active |
| C-Clamp small | 950-NE-UTCS | EUDAMEDFDA UDI | Class II | Active |
| Cranial Reference Frame A | 950-NC-CRF-A | EUDAMEDFDA UDI | Class II | Active |
| Registration probe | 950-NC-RP | EUDAMEDFDA UDI | Class II | Active |
| Bayonet Probe | 950-NE-BP-B | EUDAMEDFDA UDI | Class II | Active |
| NaviENT Accessory Kit | 955-NE-ACCK | FDA UDI | Class II | Active |
| Biopsy probe | 950-NC-BP | FDA UDI | Class II | Active |
| NaviENT | 955-NE-NE | FDA UDI | Class II | Active |
| C-Clamp medium | 950-NE-UTCM | FDA UDI | Class II | Active |
| ENT Sterilization Tray | 950-NE-STE | FDA UDI | Class II | Active |
| Dual Adapter | 950-NC-DA | EUDAMEDFDA UDI | Class II | Active |
| Cranial Reference Frame B | 950-NC-CRF-B | FDA UDI | Class II | Active |
| Universal tracker 1 B | 950-NE-UT1-B | FDA UDI | Class II | Active |
| Microscope probe | 950-NC-MP | FDA UDI | Class II | Active |
| Universal Tracker 2 | 950-NE-UT2 | EUDAMEDFDA UDI | Class II | Active |
| Navient system | 955-NC-NC | FDA UDI | Class II | Active |
| Patient Tracker | 955-NE-PT | FDA UDI | Class II | Active |
| Reducing tube 2.2mm | 950-NC-RT22 | FDA UDI | Class II | Active |
| Biopsy Sterilization Tray | 950-NC-STB | EUDAMEDFDA UDI | Class II | Active |
| Bayonet Probe | 950-NE-BP | FDA UDI | Class II | Active |
| Universal Tracker 2 B | 95-NE-UT2-B | EUDAMEDFDA UDI | Class II | Active |
| Maxillary Seeker | 950-NE-MS | EUDAMEDFDA UDI | Class II | Active |
| Cranial Sterilization Tray | 950-NC-STC | EUDAMEDFDA UDI | Class II | Active |
| Tip calibrator | 950-NC-TC | FDA UDI | Class II | Active |
| Navient Accessory kit - biopsy | 955-NC-AKB | EUDAMEDFDA UDI | Class II | Active |
| Universal Tracker 1 | 950-NE-UT1 | EUDAMEDFDA UDI | Class II | Active |
| Biopsy Aiming Device | 950-NC-BAD | FDA UDI | Class II | Active |
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