SIGNATURE(TM) 42-422404

GUDID 00880304459946

Biomet Orthopedics, LLC

Surgical drill guide, reusable

• Primary Device ID: 00880304459946
• NIH Device Record Key: 01b17161-92fa-4cc3-815f-9c362ae46cfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNATURE(TM)
• Version Model Number: 42-422404
• Catalog Number: 42-422404
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304459946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102795

FDA Product Code

• OOG: Knee arthroplasty implantation system

Sterilization

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

[00880304459946]

Moist Heat or Steam Sterilization

[00880304459946]

Moist Heat or Steam Sterilization

[00880304459946]

Moist Heat or Steam Sterilization

[00880304459946]

Moist Heat or Steam Sterilization

[00880304459946]

Moist Heat or Steam Sterilization

[00880304459946]

Moist Heat or Steam Sterilization

[00880304459946]

Moist Heat or Steam Sterilization

[00880304459946]

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: 2016-09-22

On-Brand Devices [SIGNATURE(TM)]

• 00880304716391: 42-422406
• 00880304467026: 42-422403
• 00880304459953: 42-422405
• 00880304459946: 42-422404