X2 Headset

GUDID 17290113781730

AUGMEDICS LTD

Multi-purpose stereotactic surgery system
Primary Device ID17290113781730
NIH Device Record Key7b42ccb1-eaf2-4028-8658-71dbd19510a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameX2 Headset
Version Model NumberX2001001
Company DUNS600325755
Company NameAUGMEDICS LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290113781696 [Primary]
GS117290113781730 [Package]
Contains: 07290113781696
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SBFOrthopedic Augmented Reality

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2026-02-13
Device Publish Date2025-11-19

Devices Manufactured by AUGMEDICS LTD

07290113781672 - PC Mouse2026-02-13
17290113781730 - X2 Headset2026-02-13
17290113781730 - X2 Headset2026-02-13
07290113781702 - X2 Accessories Kit2026-02-13
07290113781719 - X2 Headset Battery LARGE2026-02-13
07290113781726 - X2 Headset Battery SMALL2026-02-13
07290113781115 - Patient Marker Extender2025-03-26
07290113781122 - C-arm Ring Adaptor2025-03-26
07290113781252 - XVS C Headset IPD-60 LCD Display2025-03-26

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