Signature™ Instrumentation 42-422401

GUDID 70880304460224

Biomet Orthopedics, LLC

Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable

• Primary Device ID: 70880304460224
• NIH Device Record Key: 65ac50a3-67bf-4586-9c28-43f04866e8f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signature™ Instrumentation
• 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
• 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	00887868507069 [Primary]
GS1	70880304460224 [Unit of Use]

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

[70880304460224]

Moist Heat or Steam Sterilization

[70880304460224]

Moist Heat or Steam Sterilization

[70880304460224]

Moist Heat or Steam Sterilization

[70880304460224]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-02
• Device Publish Date: 2022-05-25

On-Brand Devices [Signature™ Instrumentation]

• 00887868262166: 110004349
• 00887868262142: 110004347
• 00887868507038: 42-411400
• 00887868507106: 42-422409
• 70880304460224: 42-422401
• 70880304507103: 42-422400
• 00887868507045: 42-411401