XVS MARKERS WITH C-LINK KIT 3 SETS PACK

GUDID 27290113781195

AUGMEDICS LTD

Multi-purpose stereotactic surgery system
Primary Device ID27290113781195
NIH Device Record Keyed2c4dc7-7954-4201-a29e-80efa5bdfbc1
Commercial Distribution StatusIn Commercial Distribution
Brand NameXVS MARKERS WITH C-LINK KIT 3 SETS PACK
Version Model NumberASP07070
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290113781181 [Primary]
GS127290113781195 [Package]
Contains: 17290113781181
Package: Shipping box [3 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

SBFOrthopedic Augmented Reality

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-26
Device Publish Date2025-03-18

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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