Signature™ Microplasty® Elite Instrumentation 42-422502

GUDID 00887868507120

Biomet Orthopedics, LLC

Surgical drill guide, reusable

• Primary Device ID: 00887868507120
• NIH Device Record Key: 09307c6f-9920-4daf-b5b5-b6e0a2e8a517
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signature™ Microplasty® Elite Instrumentation
• Version Model Number: 42-422502
• Catalog Number: 42-422502
• 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	00887868507120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102795

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

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

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

Moist Heat or Steam Sterilization

[00887868507120]

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® Elite Instrumentation]

• 00887868507144: 42-422508
• 00887868507120: 42-422502