OFFSET DELTA WIRE GUIDE 110008484

GUDID 00887868109812

Biomet Orthopedics, LLC

Surgical drill guide, reusable

• Primary Device ID: 00887868109812
• NIH Device Record Key: 491c21d8-9097-4ece-8482-fb0338401e9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OFFSET DELTA WIRE GUIDE
• Version Model Number: 110008484
• Catalog Number: 110008484
• 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	00887868109812 [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

[00887868109812]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-26

On-Brand Devices [OFFSET DELTA WIRE GUIDE]

• 00887868109812: 110008484
• 00887868463235: 110008484