Navient Accessory kit - biopsy
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Navient Accessories Kit - Biopsy EUDAMEDNavient Accessory kit - biopsy FDA UDI
- Generic Name
- Neurological stereotactic surgery system FDA UDI
- Device Name
- Navient Instruments EUDAMEDNavient Accessory kit - biopsy for use with Navient system, cranial FDA UDI
- Model / Reference
- 955-NC-AKB EUDAMEDFDA UDI
- Description
- Navient Accessory kit - biopsy for use with Navient system, cranial FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07540209955525 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540209955-NC-REUSDA EUDAMED
- 510(k) Number
- K241327 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 - biopsy by ClaroNav Kolahi Inc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K241327 also covers:
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 |
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Manufacturer
- Manufacturer
- ClaroNav Kolahi Inc
Sources (2)
- FDA UDI 551d5ddb-46a4-4fea-ab28-c03e1cbfdb0a 34 fields · synced Jun 19, 2026
- EUDAMED bb2ddcd2-13b7-420d-a898-477f1386aa36 61 fields · synced Jun 18, 2026