BIO PLUG 163010

GUDID 00880304004092

Biomet Orthopedics, LLC

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile

• Primary Device ID: 00880304004092
• NIH Device Record Key: 4eeae14a-60a4-409f-8a32-6ea0a5620fed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO PLUG
• Version Model Number: 163010
• Catalog Number: 163010
• 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@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304004092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800144

FDA Product Code

• JDS: NAIL, FIXATION, BONE

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: 2015-10-24

On-Brand Devices [BIO PLUG]

• 00880304255142: 163025
• 00880304004108: 163020
• 00880304004092: 163010
• 00880304004085: 163015
• 00880304004078: 163005