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Nexxis OR

FDA UDI

Class II (US FDA UDI)

by Barco, Inc.

Identity

Trade Name
Nexxis OR FDA UDI
Generic Name
Operating room audiovisual data/device management system FDA UDI
Device Name
NEXXIS SYSTEM X620 CM V5 FDA UDI
Model / Reference
NEXXIS system FDA UDI
Description
NEXXIS SYSTEM X620 CM V5 FDA UDI

Identifiers

Catalog Number
K9605032 FDA UDI
Primary DI / UDI-DI
05415334036833 FDA UDI
510(k) Number
K173381 FDA UDI
FDA Product Code
DXJ FDA UDI
GMDN Term
Operating room audiovisual data/device management system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2450 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Operating room audiovisual data/device management system

Nexxis OR by Barco, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Operating room audiovisual data/device management system.

Cleared under the same submission

K173381 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Barco, Inc.

Sources (1)

  • FDA UDI 52e65df5-87f6-4c59-b526-d6a457d14250 36 fields · synced May 30, 2026