Omni Mini

GUDID 00842078125533

Headless Compression Screw, Cannulated – 3.5 x 28mm

EXTREMITY MEDICAL, LLC

Orthopaedic bone screw (non-sliding)
Primary Device ID00842078125533
NIH Device Record Key137881df-3340-40a5-a64c-14ef63c6cc95
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmni Mini
Version Model Number154-35128
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
GS100842078125533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

Moist Heat or Steam Sterilization


[00842078125533]

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 Mini ]

00842078125861Omni Mini Instrument Tray
008420781256945th Metatarsal Hook Plate
00842078125670Navicular Grid Plate
00842078125663Headless Compression Screw, Cannulated – 3.5 x 50mm
00842078125632Headless Compression Screw, Cannulated – 3.5 x 45mm
00842078125601Headless Compression Screw, Cannulated – 3.5 x 40mm
00842078125571Headless Compression Screw, Cannulated – 3.5 x 35mm
00842078125540Headless Compression Screw, Cannulated – 3.5 x 30mm
00842078125533Headless Compression Screw, Cannulated – 3.5 x 28mm
00842078125526Headless Compression Screw, Cannulated – 3.5 x 26mm
00842078125502Headless Compression Screw, Cannulated – 3.5 x 24mm
00842078125496Headless Compression Screw, Cannulated – 3.5 x 22mm
00842078125489Headless Compression Screw, Cannulated – 3.5 x 20mm
00842078125472Headless Compression Screw, Cannulated – 3.5 x 18mm
00842078125465Headless Compression Screw, Cannulated – 3.5 x 16mm
00842078125373Locking Screw – 2.8 x 34mm
00842078125366Locking Screw – 2.8 x 32mm
00842078125359Locking Screw – 2.8 x 30mm
00842078125342Locking Screw – 2.8 x 28mm
00842078125335Locking Screw – 2.8 x 26mm
00842078125311Locking Screw – 2.8 x 24mm
00842078125304Locking Screw – 2.8 x 22mm
00842078125298Locking Screw – 2.8 x 20mm
00842078125281Locking Screw – 2.8 x 18mm
00842078125274Locking Screw – 2.8 x 16mm
00842078125267Locking Screw – 2.8 x 14mm
00842078125250Locking Screw – 2.8 x 12mm
00842078125243Locking Screw – 2.8 x 10mm
00842078125236Locking Screw – 2.8 x 8mm
00842078125137Non Locking Screw – 2.8 x 34mm
00842078125120Non Locking Screw – 2.8 x 32mm
00842078125113Non Locking Screw – 2.8 x 30mm
00842078125106Non Locking Screw – 2.8 x 28mm
00842078125090Non Locking Screw – 2.8 x 26mm
00842078125076Non Locking Screw – 2.8 x 24mm
00842078125069Non Locking Screw – 2.8 x 22mm
00842078125052Non Locking Screw – 2.8 x 20mm
00842078125045Non Locking Screw – 2.8 x 18mm
00842078125038Non Locking Screw – 2.8 x 16mm
00842078125021Non Locking Screw – 2.8 x 14mm
00842078125014Non Locking Screw – 2.8 x 12mm
00842078125007Non Locking Screw – 2.8 x 10mm
00842078124994Non Locking Screw – 2.8 x 8mm
00842078124871Locking Screw – 2.3 x 30mm
00842078124864Locking Screw – 2.3 x 28mm
00842078124857Locking Screw – 2.3 x 26mm
00842078124833Locking Screw – 2.3 x 24mm
00842078124826Locking Screw – 2.3 x 22mm
00842078124819Locking Screw – 2.3 x 20mm
00842078124802Locking Screw – 2.3 x 18mm

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