Rotating Marker Adaptor

GUDID 07290113780965

AUGMEDICS LTD

Multi-purpose stereotactic surgery system
Primary Device ID07290113780965
NIH Device Record Key20a4b370-bdc0-4188-aaba-2630acd3699a
Commercial Distribution StatusIn Commercial Distribution
Brand NameRotating Marker Adaptor
Version Model NumberAMCH00039
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
GS107290113780965 [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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