Swivel 3-4 mm universal tool adapter Leg up

GUDID 07290113780996

AUGMEDICS LTD

Multi-purpose stereotactic surgery system
Primary Device ID07290113780996
NIH Device Record Keyad80f2c9-5e4a-48dd-b341-a4f3e44d43ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameSwivel 3-4 mm universal tool adapter Leg up
Version Model NumberAMCRMU03
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
GS107290113780996 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290113780996]

Moist Heat or Steam Sterilization


[07290113780996]

Moist Heat or Steam Sterilization


[07290113780996]

Moist Heat or Steam Sterilization


[07290113780996]

Moist Heat or Steam Sterilization


[07290113780996]

Moist Heat or Steam Sterilization


[07290113780996]

Moist Heat or Steam Sterilization


[07290113780996]

Moist Heat or Steam Sterilization


[07290113780996]

Moist Heat or Steam Sterilization


[07290113780996]

Moist Heat or Steam Sterilization


[07290113780996]

Moist Heat or Steam Sterilization


[07290113780996]

Moist Heat or Steam Sterilization


[07290113780996]

Moist Heat or Steam Sterilization


[07290113780996]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-18
Device Publish Date2022-12-13

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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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