SIGNATURE INSTRUMENTATION 42-422508

GUDID 00880304716438

Biomet Orthopedics, LLC

Surgical drill guide, reusable

• Primary Device ID: 00880304716438
• NIH Device Record Key: 043de8f7-dc0f-4acf-84c9-a44df047d150
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNATURE INSTRUMENTATION
• Version Model Number: 42-422508
• Catalog Number: 42-422508
• 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: true
• 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	00880304716438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102795

FDA Product Code

• OIY: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive

Sterilization

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

[00880304716438]

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: 2016-10-21

On-Brand Devices [SIGNATURE INSTRUMENTATION]

• 00880304716438: 42-422508
• 00880304716421: 42-422502
• 00880304567610: 110004349
• 00880304567603: 110004348
• 00880304539013: 110004347