XVS MARKERS WITH C-LINK KIT 10 SETS PACK

GUDID 27290113781041

AUGMEDICS LTD

Multi-purpose stereotactic surgery system
Primary Device ID27290113781041
NIH Device Record Keyed604207-3458-49ac-b2c1-f1d664e1c5bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameXVS MARKERS WITH C-LINK KIT 10 SETS PACK
Version Model NumberASP07059
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
GS117290113781044 [Primary]
GS127290113781041 [Package]
Contains: 17290113781044
Package: Shipping Box [10 Units]
Discontinued: 2024-10-24
Not 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 Date2024-11-01
Device Publish Date2024-10-24

Devices Manufactured by AUGMEDICS LTD

07290113781054 - C-arm Ring Adaptor2024-11-01
07290113781078 - BNC to BNC Cable2024-11-01
07290113781085 - DVI-I to BNC Adaptor2024-11-01
07290113781092 - VGA to HDMI adaptor2024-11-01
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
27290113781041 - XVS MARKERS WITH C-LINK KIT 10 SETS PACK2024-11-01
07290113781061 - Augmedics WS-Cart assembly2024-03-26

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