VANGUARD 5-IN-1 TRIAL BEARING 32-483604

GUDID 00880304520912

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304520912
• NIH Device Record Key: 6f590bd0-67fd-45eb-acf1-ef749b7d017f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD 5-IN-1 TRIAL BEARING
• Version Model Number: 32-483604
• Catalog Number: 32-483604
• 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: true
• 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

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

Device Issuing Agency	Device ID
GS1	00880304520912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113550

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

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

Moist Heat or Steam Sterilization

[00880304520912]

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: 2016-10-21

On-Brand Devices [VANGUARD 5-IN-1 TRIAL BEARING]

• 00880304612051: 32-483690
• 00880304612044: 32-483688
• 00880304612037: 32-483686
• 00880304612020: 32-483684
• 00880304612013: 32-483682
• 00880304612006: 32-483674
• 00880304611993: 32-483670
• 00880304611986: 32-483668
• 00880304611979: 32-483666
• 00880304611962: 32-483662
• 00880304611955: 32-483654
• 00880304611948: 32-483652
• 00880304611931: 32-483650
• 00880304611924: 32-483648
• 00880304611917: 32-483646
• 00880304611900: 32-483644
• 00880304611894: 32-483634
• 00880304611887: 32-483632
• 00880304611870: 32-483630
• 00880304611863: 32-483628
• 00880304611856: 32-483626
• 00880304611849: 32-483624
• 00880304611832: 32-483622
• 00880304611825: 32-483614
• 00880304611818: 32-483612
• 00880304611801: 32-483610
• 00880304611795: 32-483608
• 00880304611788: 32-483606
• 00880304535503: 32-483660
• 00880304535497: 32-483620
• 00880304520936: 32-483602
• 00880304520929: 32-483600
• 00880304520912: 32-483604
• 00880304510494: 32-483640
• 00880304475977: 32-483664
• 00880304437517: 32-483642