Omni

GUDID 00842078115855

Straight Plate, 8 Hole

EXTREMITY MEDICAL, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00842078115855
• NIH Device Record Key: dc757da4-9445-4823-8448-69233126b60b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni
• Version Model Number: 144-20080
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842078115855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180808

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00842078115855]

Moist Heat or Steam Sterilization

[00842078115855]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-05
• Device Publish Date: 2018-10-03

On-Brand Devices [Omni]

• 00842078116593: Partially Threaded Cannulated Screw - 3.5 x 50mm
• 00842078116586: Partially Threaded Cannulated Screw - 3.5 x 45mm
• 00842078116579: Locking Screw - 3.5 x 35mm
• 00842078116562: Locking Screw - 3.5 x 30mm
• 00842078116555: Locking Screw - 3.5 x 28mm
• 00842078116548: Locking Screw - 3.5 x 26mm
• 00842078116531: Locking Screw - 3.5 x 24mm
• 00842078116524: Non-Locking Screw - 3.5 x 30mm
• 00842078116517: Non-Locking Screw - 3.5 x 28mm
• 00842078116500: Non-Locking Screw - 3.5 x 26mm
• 00842078116494: Non-Locking Screw - 3.5 x 24mm
• 00842078116487: Locking Screw - 2.8 x 30mm
• 00842078116470: Locking Screw - 2.8 x 28mm
• 00842078116463: Locking Screw - 2.8 x 26mm
• 00842078116456: Locking Screw - 2.8 x 24mm
• 00842078116449: Non-Locking Screw - 2.8 x 30mm
• 00842078116432: Non-Locking Screw - 2.8 x 28mm
• 00842078116425: Non-Locking Screw - 2.8 x 26mm
• 00842078116418: Non-Locking Screw - 2.8 x 24mm
• 00842078116074: Lisfranc Plate, Large, Right
• 00842078116067: Lisfranc Plate, Large, Left
• 00842078116050: Lisfranc Plate, Medium, Right
• 00842078116043: Lisfranc Plate, Medium, Left
• 00842078116036: Lisfranc Plate, Small, Right
• 00842078116029: Lisfranc Plate, Small, Left
• 00842078116012: Lisfranc Plate, Extra Small, Right
• 00842078116005: Lisfranc Plate, Extra Small, Left
• 00842078115992: Lapidus Plate, 5 Hole, Right
• 00842078115985: Lapidus Plate, 5 Hole, Left
• 00842078115978: T-Plate, 5 Hole, Right
• 00842078115961: T-Plate, 5 Hole, Left
• 00842078115954: T-Plate, 4 Hole, Right
• 00842078115947: T-Plate, 4 Hole, Left
• 00842078115930: Universal T-Plate, 6 Hole
• 00842078115923: Universal T-Plate, 5 Hole
• 00842078115916: Dog Bone Plate, Narrow, Long
• 00842078115909: Dog Bone Plate, Narrow, Short
• 00842078115893: X-Plate, Long, Right
• 00842078115886: X-Plate, Long, Left
• 00842078115879: X-Plate, Short, Right
• 00842078115862: X-Plate, Short, Left
• 00842078115855: Straight Plate, 8 Hole
• 00842078115848: Straight Plate, 7 Hole
• 00842078115831: Straight Plate, 6 Hole
• 00842078115824: Straight Plate, 5 Hole
• 00842078115817: Straight Plate, 4 Hole
• 00842078115800: Straight Plate, 2 Hole
• 00842078115299: PlantarFiX Compression Post - 16 mm
• 00842078115282: PlantarFiX Compression Post - 12 mm
• 00842078115275: Partially Threaded Cannulated Screw - 3.5 x 40mm