XVS Instrument Tray for Universal Tools

GUDID 07290113780293

AUGMEDICS LTD

Multi-purpose stereotactic surgery system
Primary Device ID07290113780293
NIH Device Record Key5836cc7a-e492-45d6-8786-4840661f4886
Commercial Distribution StatusIn Commercial Distribution
Brand NameXVS Instrument Tray for Universal Tools
Version Model NumberASP00027
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290113780293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290113780293]

Moist Heat or Steam Sterilization


[07290113780293]

Moist Heat or Steam Sterilization


[07290113780293]

Moist Heat or Steam Sterilization


[07290113780293]

Moist Heat or Steam Sterilization


[07290113780293]

Moist Heat or Steam Sterilization


[07290113780293]

Moist Heat or Steam Sterilization


[07290113780293]

Moist Heat or Steam Sterilization


[07290113780293]

Moist Heat or Steam Sterilization


[07290113780293]

Moist Heat or Steam Sterilization


[07290113780293]

Moist Heat or Steam Sterilization


[07290113780293]

Moist Heat or Steam Sterilization


[07290113780293]

Moist Heat or Steam Sterilization


[07290113780293]

Moist Heat or Steam Sterilization


[07290113780293]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-24
Device Publish Date2020-03-16

Devices Manufactured by AUGMEDICS LTD

07290113781115 - Patient Marker Extender2025-03-26
07290113781122 - C-arm Ring Adaptor2025-03-26
07290113781252 - XVS C Headset IPD-60 LCD Display2025-03-26
17290113781280 - XVS C Headset IPD-64 LCD Display2025-03-26
17290113781303 - XVS C Headset IPD-68 LCD Display2025-03-26
17290113781327 - XVS C Headset IPD-60 Clear Display2025-03-26
17290113781341 - XVS C Headset IPD-64 Clear Display2025-03-26
17290113781365 - XVS C Headset IPD-68 Clear Display2025-03-26

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