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Navident Procedure Kit

FDA UDI

Class II (US FDA UDI)

by Claronav

Identity

Trade Name
Navident Procedure Kit FDA UDI
Generic Name
Surgical planning/navigation-enhancement system FDA UDI
Device Name
Navident Procedure Kit - for use with the Navident System (955-ND-ND). FDA UDI
Model / Reference
955-ND-PRK FDA UDI
Description
Navident Procedure Kit - for use with the Navident System (955-ND-ND). FDA UDI

Identifiers

Primary DI / UDI-DI
07540209990021 FDA UDI
510(k) Number
K161406 FDA UDI
K210947 FDA UDI
FDA Product Code
PLV FDA UDI
GMDN Term
Surgical planning/navigation-enhancement system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical planning/navigation-enhancement system

Navident Procedure Kit by Claronav — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical planning/navigation-enhancement system.

Cleared under the same submission

K161406 also covers:

K210947 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Claronav

Sources (1)

  • FDA UDI 4b03d94e-6bbb-4ea4-bfa8-4c5788a4d60f 34 fields · synced May 31, 2026