Premier™ 32-487263

GUDID 00887868496332

Biomet Orthopedics, LLC

Knee tibia prosthesis trial, reusable

• Primary Device ID: 00887868496332
• NIH Device Record Key: 7dd1f7ab-18a2-43c0-bfad-fb3acfd1b471
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier™
• Version Model Number: 32-487263
• Catalog Number: 32-487263
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868496332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142933

FDA Product Code

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

Sterilization

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

[00887868496332]

Moist Heat or Steam Sterilization

[00887868496332]

Moist Heat or Steam Sterilization

[00887868496332]

Moist Heat or Steam Sterilization

[00887868496332]

Moist Heat or Steam Sterilization

[00887868496332]

Moist Heat or Steam Sterilization

[00887868496332]

Moist Heat or Steam Sterilization

[00887868496332]

Moist Heat or Steam Sterilization

[00887868496332]

Moist Heat or Steam Sterilization

[00887868496332]

Moist Heat or Steam Sterilization

[00887868496332]

Moist Heat or Steam Sterilization

[00887868496332]

Moist Heat or Steam Sterilization

[00887868496332]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-16
• Device Publish Date: 2022-05-08

On-Brand Devices [Premier™]

• 00887868496387: 32-487268
• 00887868496370: 32-487267
• 00887868496363: 32-487266
• 00887868496356: 32-487265
• 00887868496349: 32-487264
• 00887868496332: 32-487263
• 00887868496325: 32-487262
• 00887868496318: 32-487261
• 00887868496301: 32-487260