Signature™ Microplasty® Premier™ Instrumentation 42-422505

GUDID 00887868507137

Biomet Orthopedics, LLC

Surgical drill guide, reusable

• Primary Device ID: 00887868507137
• NIH Device Record Key: b4c69138-f90d-4112-8f86-599d6ad5c3e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signature™ Microplasty® Premier™ Instrumentation
• Version Model Number: 42-422505
• Catalog Number: 42-422505
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868507137 [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

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

[00887868507137]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-12
• Device Publish Date: 2021-04-02

On-Brand Devices [Signature™ Microplasty® Premier™ Instrumentation]

• 00887868507137: 42-422505
• 00887868507076: 42-422403