Model: Nexxis system
Catalog: K9610426
DI: 05415334062412
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
NEXXIS ULTIMAX KIT2
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c0bec227-bf08-4b2a-b5f0-dc585f484e11
Distribution Status:
In Commercial Distribution
DUNS Number:
371618773
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05415334062412
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58117
Name: Operating room audiovisual data/device management system
Definition:
A mains electricity (AC-powered) device assembly designed to provide operating room (OR) staff with a single point of management to operate electromechanical/electronic medical devices of different makes during surgery. It is a computer-based integrated hardware/software application that typically consists of a base unit (outside the sterile field or the OR) to which all device cabling is connected, and software that runs on an off-the-shelf computer with a touchscreen (in the OR). The system is intended to manipulate devices such as OR lights, OR tables, cameras, video endoscope images, and monitors; it may also be used to manage patient data from these devices.
FDA Product Codes
DXJ
Display, Cathode-Ray Tube, Medical
Premarket Submissions
Submission Number:
K173381
Supplement Number:
000