XVS L-Headset IPD-64 LCD Display

GUDID 07290113780811

AUGMEDICS LTD

Multi-purpose stereotactic surgery system
Primary Device ID07290113780811
NIH Device Record Keyb26f2b4d-91bd-4869-9e45-a97d6feb98f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameXVS L-Headset IPD-64 LCD Display
Version Model NumberAHMD642WLD
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
GS107290113780811 [Primary]
GS117290113780818 [Package]
Package: Shipping Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-18
Device Publish Date2021-01-10

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07290113781092 - VGA to HDMI adaptor2024-11-01
07290113781108 - HDMI to HDMI cable2024-11-01
27290113781034 - XVS MARKERS FOR ASC KIT 3 SETS PACK2024-11-01
27290113781041 - XVS MARKERS WITH C-LINK KIT 10 SETS PACK2024-11-01
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