Omni Lapidus Plating

GUDID 00842078130926

SlotLock Lapidus Plate, Slim, 4-Hole

EXTREMITY MEDICAL, LLC

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00842078130926
NIH Device Record Key9b662b7b-81b0-454e-8ffe-7ce05fb66604
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmni Lapidus Plating
Version Model Number164-11401
Company DUNS832720358
Company NameEXTREMITY MEDICAL, LLC
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS100842078130926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


[00842078130926]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-26
Device Publish Date2024-07-18

On-Brand Devices [Omni Lapidus Plating ]

00842078133972SlotLock Lapidus Plate Caddy
00842078130957SlotLock Lapidus Plate, Straight, 4-Hole
00842078130940SlotLock Lapidus Plate, 6-Hole, Right
00842078130933SlotLock Lapidus Plate, 6-Hole, Left
00842078130926SlotLock Lapidus Plate, Slim, 4-Hole
00842078130919SlotLock Lapidus Plate, 5-Hole, Right
00842078130902SlotLock Lapidus Plate, 5-Hole, Left

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