Identity
- Trade Name
- Bayonet Probe - B EUDAMEDBayonet Probe FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- Navient Instruments EUDAMEDbayonet probe B for Navient FDA UDI
- Model / Reference
- 950-NE-BP-B EUDAMEDFDA UDI
- Description
- bayonet probe B for Navient FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540209955204 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540209955-NC-REUSDA EUDAMED
- Direct Marketing DI
- 07540209955204 EUDAMED
- 510(k) Number
- K163439 FDA UDI
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Neurological stereotactic surgery system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Neurological stereotactic surgery system
Bayonet Probe by ClaroNav Kolahi Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Neurological stereotactic surgery system.
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Cleared under the same submission
K163439 also covers:
- Bayonet Probe — ClaroNav Kolahi Inc
- C-Clamp Large — ClaroNav Kolahi Inc
- C-Clamp XL — ClaroNav Kolahi Inc
- C-Clamp medium — ClaroNav Kolahi Inc
- C-Clamp small — ClaroNav Kolahi Inc
- ENT Sterilization Tray — ClaroNav Kolahi Inc
- Frontal Seeker — ClaroNav Kolahi Inc
- Frontal Seeker B — ClaroNav Kolahi Inc
- Maxillary Seeker — ClaroNav Kolahi Inc
- Maxillary Seeker B — ClaroNav Kolahi Inc
- NaviENT — ClaroNav Kolahi Inc
- NaviENT Accessory Kit — ClaroNav Kolahi Inc
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ClaroNav Kolahi Inc
Sources (2)
- FDA UDI 14ed739b-aa81-4404-918b-42dc62ad8fad 34 fields · synced Jun 19, 2026
- EUDAMED 6971a6ff-76c6-4330-8056-b8e943816ba3 61 fields · synced Jun 19, 2026