Device
Accessory of medical device EndoNaut (Standalone) SW (UDI: 03760262480022)
Manufacturer
THERENVA
THERENVA
Model: TS1CA2DS1-2
DI: 03760262480039
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Accessory of medical device EndoNaut (Standalone) SW (UDI: 03760262480022)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5ad05c6d-68dd-4df6-913f-0f37041dfbde
Distribution Status:
In Commercial Distribution
DUNS Number:
296780716
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:
03760262480039
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61496
Name: Surgical planning/navigation-enhancement system
Definition:
A mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.
FDA Product Codes
LLZ
System, Image Processing, Radiological
Premarket Submissions
Submission Number:
K222070
Supplement Number:
000