XVS Headset IPD-68 LCD Display

GUDID 07290113780583

AUGMEDICS LTD

Multi-purpose stereotactic surgery system
Primary Device ID07290113780583
NIH Device Record Key1d2205d4-7d5d-419f-afb2-1a4aa59a9b14
Commercial Distribution StatusIn Commercial Distribution
Brand NameXVS Headset IPD-68 LCD Display
Version Model NumberAHMD681WLD
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
GS107290113780583 [Primary]
GS117290113780580 [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 Date2020-08-14
Device Publish Date2020-08-06

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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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