Contours VPS Volar Plate DH0460CE

GUDID 18054242514213

K-WIRE 1.4MM X 127MM

ORTHOFIX SRL

Orthopaedic bone wire

• Primary Device ID: 18054242514213
• NIH Device Record Key: cd9351a9-c823-437d-a49f-9b7b389d3b42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contours VPS Volar Plate
• Version Model Number: 1
• Catalog Number: DH0460CE
• 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: 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

• Length: 127 Millimeter
• Outer Diameter: 1.4 Millimeter
• Length: 127 Millimeter
• Outer Diameter: 1.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18054242514213 [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

[18054242514213]

Moist Heat or Steam Sterilization

[18054242514213]

Moist Heat or Steam Sterilization

Device Entry Metadata

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