Tablet computer + Pre-installed Software

GUDID 07290113780262

AUGMEDICS LTD

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system
Primary Device ID07290113780262
NIH Device Record Keycea6e3d4-812d-4295-af68-fc95cd8d7f7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTablet computer + Pre-installed Software
Version Model NumberACC00001
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
GS107290113780262 [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 Date2020-03-24
Device Publish Date2020-03-16

Devices Manufactured by AUGMEDICS LTD

07290113781061 - Augmedics WS-Cart assembly2024-03-26
07290113780996 - Swivel 3-4 mm universal tool adapter Leg up2023-09-18
07290113781009 - Standard xvision tray, instruments included2023-09-18
07290113781016 - Standard perc pin tray, instruments included2023-09-18
17290113780986 - XVS STERILE COMPONENTS KIT2021-09-13
07290113780712 - 8” Tablet 2021-08-13
07290113780729 - 8” Tablet Docking2021-08-13
07290113780859 - Perc Pin Tray2021-08-13

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