Lapidus Instruments

GUDID 00842078126035

Instrumentation Tray

EXTREMITY MEDICAL, LLC

Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable
Primary Device ID00842078126035
NIH Device Record Key05ca6015-557d-4011-9fc2-3abaf6f90211
Commercial Distribution StatusIn Commercial Distribution
Brand NameLapidus Instruments
Version Model Number168-00000
Company DUNS832720358
Company NameEXTREMITY MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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
GS100842078126035 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


[00842078126035]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-08
Device Publish Date2024-03-29

Devices Manufactured by EXTREMITY MEDICAL, LLC

00842078103142 - IO FiX2024-04-08 IO FiX 2.0 Instrument Tray and Caddy
00842078107928 - XMCP2024-04-08 XMCP Instrument Tray
00842078108246 - ApeX2024-04-08 Apex Instrument Tray
00842078109366 - CarpalFiX2024-04-08 Instrument Tray
00842078110119 - AlignX2024-04-08 AlignX Implant Tray
00842078112243 - Axis 2024-04-08 AXIS Instrument Tray
00842078114612 - KinematX2024-04-08 KinematX Total Instrument Tray
00842078116098 - Omni2024-04-08 OMNI Plating System Tray

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