Perc Pin 125mm 5 units Package

GUDID 27290113780938

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 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 ID27290113780938
NIH Device Record Key5f5c3743-548c-489b-901c-ecc89d564d6c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerc Pin 125mm 5 units Package
Version Model NumberAMCH07012
Company DUNS600325755
Company NameAUGMEDICS LTD
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS107290113780934 [Unit of Use]
GS117290113780931 [Primary]
GS127290113780938 [Package]
Contains: 17290113780931
Package: Box of 20 units [20 Units]
In Commercial Distribution
GS137290113780935 [Package]
Package: Shipping Box [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


[27290113780938]

Moist Heat or Steam Sterilization


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

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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