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Arvis ®

FDA UDI

Class II (US FDA UDI)

by Kico Knee Innovation Company Pty Limited

Identity

Trade Name
ARVIS ® FDA UDI
Generic Name
Surgical optical-tracking spatial marker, reusable FDA UDI
Device Name
Tracker C FDA UDI
Model / Reference
11900 FDA UDI
Description
Tracker C FDA UDI

Identifiers

Primary DI / UDI-DI
00850012315209 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Surgical optical-tracking spatial marker, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical optical-tracking spatial marker, reusable

Arvis ® by Kico Knee Innovation Company Pty Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical optical-tracking spatial marker, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kico Knee Innovation Company Pty Limited

Sources (1)

  • FDA UDI ab3ef68e-2f25-4437-a73f-d0d0d2309e82 33 fields · synced Jun 8, 2026