SOLID HEXALOBULAR DRIVER AO 110009965

GUDID 00887868111419

Biomet Orthopedics, LLC

Orthopaedic implant driver

• Primary Device ID: 00887868111419
• NIH Device Record Key: 49f8d692-cb81-4000-8dff-9d0353ab5b0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLID HEXALOBULAR DRIVER AO
• Version Model Number: 110009965
• Catalog Number: 110009965
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868111419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140891

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00887868111419]

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: 2016-09-26

On-Brand Devices [SOLID HEXALOBULAR DRIVER AO]

• 00887868111419: 110009965
• 00887868111402: 110009963
• 00887868111396: 110009961
• 00887868522796: 110009965
• 00887868522789: 110009963
• 00887868522772: 110009961