Identity
- Trade Name
- Navient ENT Accessory Kit - B EUDAMEDNaviENT Accessory Kit-B FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- Navient Instruments EUDAMEDNavient Accessory Kit-B for use with the Navient surgical navigation system FDA UDI
- Model / Reference
- 955-NE-ACCK-B EUDAMEDFDA UDI
- Description
- Navient Accessory Kit-B for use with the Navient surgical navigation system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540209955976 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540209955-NC-REUSDA 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Neurological stereotactic surgery system
NaviENT Accessory Kit-B 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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- Leksell Stereotactic System — Elekta Instrument AB · Class II
Cleared under the same submission
K163439 also covers:
- Bayonet Probe — ClaroNav Kolahi Inc
- 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
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ClaroNav Kolahi Inc
Sources (2)
- FDA UDI de0261a5-3bd7-434b-a8f4-73e93f3ae3be 34 fields · synced Jun 19, 2026
- EUDAMED 90b2a315-6068-46b9-87da-b061a1c75de3 61 fields · synced Jun 19, 2026