BioDrive Cannulated Screw System 14-450390

GUDID 00880304592773

3.2MM X 250MM K-WIRE, (THREADED TROCAR TIP)

Biomet Orthopedics, LLC

Orthopaedic bone wire Orthopaedic bone wire

• Primary Device ID: 00880304592773
• NIH Device Record Key: 005f09f1-42c5-4b69-b11a-d5ed8cbfb374
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioDrive Cannulated Screw System
• Version Model Number: 14-450390
• Catalog Number: 14-450390
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, 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: 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: 1-800-348-9500
• Email: customerservice@biomet.com
• Phone: 1-800-348-9500
• Email: customerservice@biomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304592773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831005

FDA Product Code

• HTY: Pin, Fixation, Smooth

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: 2016-10-03

On-Brand Devices [BioDrive Cannulated Screw System]

• 00880304592773: 3.2MM X 250MM K-WIRE, (THREADED TROCAR TIP)
• 00880304592766: 1.8MM X 200MM K-WIRE, (THREADED TROCAR TIP)
• 00880304592759: 1.6MM X 150MM K-WIRE, (THREADED TROCAR TIP)
• 00880304592742: 1.1MM X 150MM K-WIRE, (THREADED TROCAR TIP)
• 00880304592735: 3.2MM X 250MM K-WIRE, (TROCAR TIP)
• 00880304592728: 1.8MM X 200MM K-WIRE, (TROCAR TIP)
• 00880304592711: 1.6MM X 150MM K-WIRE, (TROCAR TIP)
• 00880304592704: 1.1MM X 150MM K-WIRE, (TROCAR TIP)