VANGUARD UNIVERSAL 5-IN-1 TIBIAL 32-483864

GUDID 00880304443815

Biomet Orthopedics, LLC

Knee tibia prosthesis trial

• Primary Device ID: 00880304443815
• NIH Device Record Key: eeb8a3b5-1869-4c48-91e6-cbb4e4861d37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VANGUARD UNIVERSAL 5-IN-1 TIBIAL
• Version Model Number: 32-483864
• Catalog Number: 32-483864
• 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

• 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 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 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 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	00880304443815 [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

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

Moist Heat or Steam Sterilization

[00880304443815]

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 UNIVERSAL 5-IN-1 TIBIAL]

• 00880304443877: 32-483830
• 00880304443860: 32-483824
• 00880304443853: 32-483820
• 00880304443846: 32-483822
• 00880304443839: 32-483828
• 00880304443822: 32-483848
• 00880304443815: 32-483864
• 00880304443808: 32-483842
• 00880304443792: 32-483826
• 00880304443785: 32-483850
• 00880304443778: 32-483844
• 00880304443761: 32-483846
• 00880304443730: 32-483840
• 00880304443716: 32-483832
• 00880304443709: 32-483860
• 00880304443693: 32-483834
• 00880304443679: 32-483852
• 00880304443655: 32-483814
• 00880304443631: 32-483854
• 00880304443624: 32-483862
• 00880304443617: 32-483812
• 00880304436596: 32-483800
• 00880304436589: 32-483808
• 00880304436572: 32-483806
• 00880304436558: 32-483804
• 00880304436534: 32-483802
• 00880304436510: 32-483810