Swivel 7.5-9mm Universal tool Adapter Leg Down

GUDID 07290113780064

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 ID07290113780064
NIH Device Record Key458d3b4d-c11e-4fce-a68e-5d7857af3c0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSwivel 7.5-9mm Universal tool Adapter Leg Down
Version Model NumberAMCRMD75
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290113780064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290113780064]

Moist Heat or Steam Sterilization


[07290113780064]

Moist Heat or Steam Sterilization


[07290113780064]

Moist Heat or Steam Sterilization


[07290113780064]

Moist Heat or Steam Sterilization


[07290113780064]

Moist Heat or Steam Sterilization


[07290113780064]

Moist Heat or Steam Sterilization


[07290113780064]

Moist Heat or Steam Sterilization


[07290113780064]

Moist Heat or Steam Sterilization


[07290113780064]

Moist Heat or Steam Sterilization


[07290113780064]

Moist Heat or Steam Sterilization


[07290113780064]

Moist Heat or Steam Sterilization


[07290113780064]

Moist Heat or Steam Sterilization


[07290113780064]

Moist Heat or Steam Sterilization


[07290113780064]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-24
Device Publish Date2020-03-16

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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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