LSP Titanium Humeral Plate 99-TP1111

GUDID 18054242510505

K-WIRES (D. 2MM) L. 200MM (PACK OF 4) STERILE

ORTHOFIX SRL

Orthopaedic bone wire Orthopaedic bone wire

• Primary Device ID: 18054242510505
• NIH Device Record Key: 658c4d15-28cf-42b9-a651-a4d8f48c506e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LSP Titanium Humeral Plate
• Version Model Number: 1
• Catalog Number: 99-TP1111
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +039456719000
• Email: info@orthofix.it
• Phone: +039456719000
• Email: info@orthofix.it

Device Dimensions

• Length: 200 Millimeter
• Outer Diameter: 2 Millimeter
• Length: 200 Millimeter
• Outer Diameter: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054242510505 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062920

FDA Product Code

• KTW: Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-01

On-Brand Devices [LSP Titanium Humeral Plate]

• 18054242510529: DRILL BIT (D. 3.2MM) QUICK CONNECT STERILE
• 18054242510505: K-WIRES (D. 2MM) L. 200MM (PACK OF 4) STERILE
• 18033509852312: LOCKING SCREW 2,4X55 MM STERILE
• 18033509852305: LOCKING SCREW 2,4X50 MM STERILE
• 18033509852299: LOCKING SCREW 2,4X45 MM STERILE
• 18033509852282: LOCKING SCREW 2,4X40 MM STERILE
• 18033509852275: LOCKING SCREW 2,4X35 MM STERILE
• 18033509852268: LOCKING SCREW 2,4X30 MM STERILE
• 18033509852251: LOCKING SCREW 2,4X25 MM STERILE
• 18033509852244: LOCKING SCREW 2,4X20 MM STERILE
• 18033509851940: LSP LEFT HUMERUS STERILE TITANIUM PLATE
• 18033509851933: LSP RIGHT HUMERUS STERILE TITANIUM PLATE