8” Tablet

GUDID 07290113780712

AUGMEDICS LTD

Multi-purpose stereotactic surgery system
Primary Device ID07290113780712
NIH Device Record Key0f7f3e97-1232-4a23-95f8-8cfec89f0d5d
Commercial Distribution StatusIn Commercial Distribution
Brand Name8” Tablet
Version Model NumberACC00310
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
GS107290113780712 [Primary]

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 Date2021-08-13
Device Publish Date2021-08-05

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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