Navient Accessory kit - cranial

FDA UDI

Class II (US FDA UDI)

by ClaroNav Kolahi Inc

Identity

Trade Name: Navient Accessory kit - cranial FDA UDI
Generic Name: Neurological stereotactic surgery system FDA UDI
Device Name: Navient Accessory kit for use with Navient system, cranial FDA UDI
Model / Reference: 955-NC-AKC FDA UDI
Description: Navient Accessory kit for use with Navient system, cranial FDA UDI

Identifiers

Primary DI / UDI-DI: 07540209955518 FDA UDI
510(k) Number: K241327 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Neurological stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Neurological stereotactic surgery system

Navient Accessory kit - cranial by ClaroNav Kolahi Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K241327 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: ClaroNav Kolahi Inc

Sources (1)

FDA UDI 195abb63-9310-4b72-936a-e7841a1b32d0 34 fields · synced Jun 1, 2026