SIGNATURE 42-422401

GUDID 00880304460225

Biomet Orthopedics, LLC

Fluted surgical drill bit, reusable

• Primary Device ID: 00880304460225
• NIH Device Record Key: 360c52fa-1ba0-48c2-958e-b628c7befaec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIGNATURE
• Version Model Number: 42-422401
• Catalog Number: 42-422401
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 2
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304460225 [Primary]
GS1	70880304460224 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102795

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[00880304460225]

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]

• 00880304928510: 42-422505
• 00880304927490: 42-422411
• 00880304520905: 592815
• 00880304516373: 42-100103
• 00880304516328: 42-100104
• 00880304516304: 42-100102
• 00880304516298: 42-100101
• 00880304507104: 42-422400
• 00880304460225: 42-422401
• 00887868273407: SSI004923