VANGUARD(TM) PS FEMORAL TRIAL 32-483108

GUDID 00880304348677

Biomet Orthopedics, LLC

Knee femur prosthesis trial

• Primary Device ID: 00880304348677
• NIH Device Record Key: f548834d-5c78-49ab-a285-8b5068a8dda4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD(TM) PS FEMORAL TRIAL
• Version Model Number: 32-483108
• Catalog Number: 32-483108
• 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
• 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
• 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
• 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 Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304348677 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113550

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

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

Moist Heat or Steam Sterilization

[00880304348677]

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: 2016-09-22

On-Brand Devices [VANGUARD(TM) PS FEMORAL TRIAL]

• 00880304447943: 32-483133
• 00880304447905: 32-483113
• 00880304348806: 32-483136
• 00880304348790: 32-483134
• 00880304348783: 32-483132
• 00880304348776: 32-483130
• 00880304348769: 32-483128
• 00880304348752: 32-483126
• 00880304348745: 32-483124
• 00880304348738: 32-483122
• 00880304348721: 32-483120
• 00880304348714: 32-483116
• 00880304348707: 32-483114
• 00880304348691: 32-483112
• 00880304348684: 32-483110
• 00880304348677: 32-483108
• 00880304348660: 32-483106
• 00880304348653: 32-483104
• 00880304348646: 32-483102
• 00880304348639: 32-483100