PREMIER 32-487266

GUDID 00880304434608

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304434608
• NIH Device Record Key: 5e851100-6e9c-4796-8372-11464ed528ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PREMIER
• Version Model Number: 32-487266
• Catalog Number: 32-487266
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304434608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142933

FDA Product Code

• MBV: Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer

Sterilization

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

[00880304434608]

Moist Heat or Steam Sterilization

[00880304434608]

Moist Heat or Steam Sterilization

[00880304434608]

Moist Heat or Steam Sterilization

[00880304434608]

Moist Heat or Steam Sterilization

[00880304434608]

Moist Heat or Steam Sterilization

[00880304434608]

Moist Heat or Steam Sterilization

[00880304434608]

Moist Heat or Steam Sterilization

[00880304434608]

Moist Heat or Steam Sterilization

[00880304434608]

Moist Heat or Steam Sterilization

[00880304434608]

Moist Heat or Steam Sterilization

[00880304434608]

Moist Heat or Steam Sterilization

[00880304434608]

Moist Heat or Steam Sterilization

[00880304434608]

Moist Heat or Steam Sterilization

[00880304434608]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-21

On-Brand Devices [PREMIER]

• 00880304465497: 32-484638
• 00880304464902: 32-484637
• 00880304434776: 32-487267
• 00880304434745: 32-487262
• 00880304434721: 32-487261
• 00880304434707: 32-487263
• 00880304434677: 32-487265
• 00880304434660: 32-487268
• 00880304434653: 32-487260
• 00880304434622: 32-487264
• 00880304434608: 32-487266