Omni Mini

GUDID 00842078125533

Headless Compression Screw, Cannulated – 3.5 x 28mm

EXTREMITY MEDICAL, LLC

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00842078125533
• NIH Device Record Key: 137881df-3340-40a5-a64c-14ef63c6cc95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni Mini
• Version Model Number: 154-35128
• Company DUNS: 832720358
• Company Name: EXTREMITY MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842078125533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221362

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-26
• Device Publish Date: 2024-07-18

On-Brand Devices [Omni Mini ]

• 00842078125861: Omni Mini Instrument Tray
• 00842078125694: 5th Metatarsal Hook Plate
• 00842078125670: Navicular Grid Plate
• 00842078125663: Headless Compression Screw, Cannulated – 3.5 x 50mm
• 00842078125632: Headless Compression Screw, Cannulated – 3.5 x 45mm
• 00842078125601: Headless Compression Screw, Cannulated – 3.5 x 40mm
• 00842078125571: Headless Compression Screw, Cannulated – 3.5 x 35mm
• 00842078125540: Headless Compression Screw, Cannulated – 3.5 x 30mm
• 00842078125533: Headless Compression Screw, Cannulated – 3.5 x 28mm
• 00842078125526: Headless Compression Screw, Cannulated – 3.5 x 26mm
• 00842078125502: Headless Compression Screw, Cannulated – 3.5 x 24mm
• 00842078125496: Headless Compression Screw, Cannulated – 3.5 x 22mm
• 00842078125489: Headless Compression Screw, Cannulated – 3.5 x 20mm
• 00842078125472: Headless Compression Screw, Cannulated – 3.5 x 18mm
• 00842078125465: Headless Compression Screw, Cannulated – 3.5 x 16mm
• 00842078125373: Locking Screw – 2.8 x 34mm
• 00842078125366: Locking Screw – 2.8 x 32mm
• 00842078125359: Locking Screw – 2.8 x 30mm
• 00842078125342: Locking Screw – 2.8 x 28mm
• 00842078125335: Locking Screw – 2.8 x 26mm
• 00842078125311: Locking Screw – 2.8 x 24mm
• 00842078125304: Locking Screw – 2.8 x 22mm
• 00842078125298: Locking Screw – 2.8 x 20mm
• 00842078125281: Locking Screw – 2.8 x 18mm
• 00842078125274: Locking Screw – 2.8 x 16mm
• 00842078125267: Locking Screw – 2.8 x 14mm
• 00842078125250: Locking Screw – 2.8 x 12mm
• 00842078125243: Locking Screw – 2.8 x 10mm
• 00842078125236: Locking Screw – 2.8 x 8mm
• 00842078125137: Non Locking Screw – 2.8 x 34mm
• 00842078125120: Non Locking Screw – 2.8 x 32mm
• 00842078125113: Non Locking Screw – 2.8 x 30mm
• 00842078125106: Non Locking Screw – 2.8 x 28mm
• 00842078125090: Non Locking Screw – 2.8 x 26mm
• 00842078125076: Non Locking Screw – 2.8 x 24mm
• 00842078125069: Non Locking Screw – 2.8 x 22mm
• 00842078125052: Non Locking Screw – 2.8 x 20mm
• 00842078125045: Non Locking Screw – 2.8 x 18mm
• 00842078125038: Non Locking Screw – 2.8 x 16mm
• 00842078125021: Non Locking Screw – 2.8 x 14mm
• 00842078125014: Non Locking Screw – 2.8 x 12mm
• 00842078125007: Non Locking Screw – 2.8 x 10mm
• 00842078124994: Non Locking Screw – 2.8 x 8mm
• 00842078124871: Locking Screw – 2.3 x 30mm
• 00842078124864: Locking Screw – 2.3 x 28mm
• 00842078124857: Locking Screw – 2.3 x 26mm
• 00842078124833: Locking Screw – 2.3 x 24mm
• 00842078124826: Locking Screw – 2.3 x 22mm
• 00842078124819: Locking Screw – 2.3 x 20mm
• 00842078124802: Locking Screw – 2.3 x 18mm