Contours VPS Volar Plate DH0468CE

GUDID 18054242513766

DRILL BIT, 3.5MM, AO QUICK CONNECT

ORTHOFIX SRL

Orthopaedic bone wire Orthopaedic bone wire

• Primary Device ID: 18054242513766
• NIH Device Record Key: 32871bad-88e8-4c11-b09b-b39e1f76fade
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contours VPS Volar Plate
• Version Model Number: 1
• Catalog Number: DH0468CE
• Company DUNS: 438793622
• Company Name: ORTHOFIX SRL
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

• Outer Diameter: 3.5 Millimeter
• Outer Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054242513766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102201

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[18054242513766]

Moist Heat or Steam Sterilization

[18054242513766]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-18
• Device Publish Date: 2016-09-16

On-Brand Devices [Contours VPS Volar Plate]

• 18054242514213: K-WIRE 1.4MM X 127MM
• 18054242513766: DRILL BIT, 3.5MM, AO QUICK CONNECT